Combining tDCS and CILT in Non-fluent Aphasia

Stroke Clinical Trial

Official title:

Combining Cerebellar tDCS and Constraint-induced Language Therapy in Non-fluent Aphasia: a Novel Approach to Target Discourse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05561400
• Other study ID #: tDCS
• Status: Completed
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The long-term goal of this work is to determine if combining a highly intensive, task-specific behavioral language intervention with modulation of the efferent cerebellar-cortical pathway using transcranial direct current stimulation (tDCS) has a positive influence on discourse, verbal fluency and working memory in individuals with non-fluent aphasia after stroke. And if these changes can be related to neuroplastic change in the cerebellar cortical pathway indirectly measured through neurophysiologic changes using spectral electroencephalogram (EEG). The initial phase includes the proposed pilot study data from which will be used to inform a larger clinical trial. The primary aims of this pilot are to 1) determine the effect of combining cerebellar tDCS with constraint-induced language therapy (CILT) on language as measured by a verbal fluency task and discourse task in a small population and 2) identify the tolerance of the intervention and barriers to participation measured by the adverse events questionnaire that will inform the methodology of a larger study. The secondary aims include estimating the size of the treatment effect on 1) delta percentage in F3, F7 and Fp1 compared to F4, F8, and Fp2 using resting state EEG spectral analysis and coherence, 2) working memory as measured by the score on the n-back test and 3) quality of life as measured by the Stroke Aphasia Quality of Life survey tool. The secondary aims will be used to determine the utility of these measures in a larger clinical trial.

This is a prospective, crossover study, sham-controlled intervention study with two intervention conditions delivered across 6 intervention sessions (3x/week for two weeks) with a 4-week washout in between. Conditions include: 1) sham cerebellar tDCS and 2) real cerebellar tDCS delivered at 2mA across 20 minutes. Each of these will be delivered during CILT intervention with a licensed, certified speech-language pathologist trained in CILT. Once tDCS stimulation has ended, CILT will continue to be delivered for an additional 25 minutes. Assessments of discourse, verbal fluency, working memory and EEG spectral analysis will be conducted at four timepoints, before and after each intervention phase.

Description:

This is a prospective sham-controlled, cross-over design. Eligible participants must be over the age of 18 years, be > least 6 months post unilateral cortical stroke and diagnosed with mild to moderate non-fluent aphasia. Additional inclusion/exclusionary criteria have been specified in and approved by the IRB. Six to seven participants are expected to be recruited and screened, with the goal to enroll and complete the study with four individuals who will be randomly assigned to receive either sham or real condition first. The two intervention conditions include: 1) andodal tDCS (2mA) to the right posterior-lateral cerebellum and 2) sham tDCS to the right posterior-lateral cerebellum. The participants will receive 20 minutes of tDCS (sham or real) during CILT followed by an additional 25 minutes of CILT alone. Each condition will be administered 3 days per week for two weeks for a total of 6 intervention sessions with a 4-week washout period between.

For tDCS (TCT-Research Version tDCS Stimulator, Hong Kong), two 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting the posterior lateral cerebellum and the cathode will be placed on the right shoulder. The electrode placement will be the same across both conditions. The CILT behavioral intervention will be led by a certified, licensed speech-language pathologist and a graduate student researcher and will follow the guidelines of CILT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over the age of 18 years

• history of stroke

• diagnosed with non-fluent aphasia.

• be able to independently understand simple directions,

• use some speech to communicate,

• have access to reliable transportation (including taxi and/or other transportation services),

• fluent in English.

Exclusion Criteria:

• Pregnancy,

• history of seizures,

• any metal implants in the body (excluding dental fillings),

• history of migraines,

• psoriasis or eczema affecting the scalp,

• history of a head injury such as a concussion

• diagnosis of a mental health or neurological condition/disease.

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Brain Injuries
• Non-fluent Aphasia
• Stroke

Intervention

Device:
• tDCS
5x5 saline-soaked sponge electrodes will be used with the cathode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the anode will be placed on the right shoulder. The electrode placement will be the same across both conditions.

Other:
• Placebo
sham tDCS to the right cerebellum

Locations

Country	Name	City	State
United States	University of Minnesota	Duluth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discourse Analysis: Picture Description	Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance	Initial Assessment/Baseline: Visit 2
Primary	Discourse Analysis: Picture Description	Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance	Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Primary	Discourse Analysis: Picture Description	Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance	Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Primary	Discourse Analysis: Picture Description	Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance	Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Primary	Discourse Analysis: Story Retell	Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance	Initial Assessment/Baseline: Visit 2
Primary	Discourse Analysis: Story Retell	Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance	Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Primary	Discourse Analysis: Story Retell	Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance	Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Primary	Discourse Analysis: Story Retell	Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance	Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Primary	Discourse Analysis: Procedural	Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance	Initial Assessment/Baseline: Visit 2
Primary	Discourse Analysis: Procedural	Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance	Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Primary	Discourse Analysis: Procedural	Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance	Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Primary	Discourse Analysis: Procedural	Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance	Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Primary	Verbal fluency: Semantic	Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17	Initial Assessment/Baseline: Visit 2
Primary	Verbal fluency: Semantic	Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17	Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Primary	Verbal fluency: Semantic	Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17	Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Primary	Verbal fluency: Semantic	Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17	Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Primary	Verbal fluency: Phonemic	Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17	Initial Assessment/Baseline: Visit 2
Primary	Verbal fluency: Phonemic	Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17	Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Primary	Verbal fluency: Phonemic	Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17	Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Primary	Verbal fluency: Phonemic	Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17	Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Secondary	Working Memory	Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better	Initial Assessment/Baseline: Visit 2
Secondary	Working Memory	Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better	Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Secondary	Working Memory	Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better	Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Secondary	Working Memory	Participant will complete the n-back test. The score represents the raw score, total items minus errors. The higher the score the better	Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Secondary	EEG: Power spectral analysis	Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better. Measures from right and left fronto-temporal regions will be calculated for analysis.	Initial Assessment/Baseline: Visit 2
Secondary	EEG: Power spectral analysis	Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better. Measures from right and left fronto-temporal regions will be calculated for analysis.	Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Secondary	EEG: Power spectral analysis	Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better.Measures from right and left fronto-temporal regions will be calculated for analysis.	Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Secondary	EEG: Power spectral analysis	Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better. Measures from right and left fronto-temporal regions will be calculated for analysis.	Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Secondary	EEG: Coherence	Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.	Initial Assessment/Baseline: Visit 2
Secondary	EEG: Coherence	Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.	Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Secondary	EEG: Coherence	Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.	Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Secondary	EEG: Coherence	Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Coherence coefficient will be calculated in the right and left fronto-temporal regions. Higher correlation is associated with more functional connectivity.	Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline
Secondary	Stroke Aphasia Quality of Life (SA-QOL)	Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better	Initial Assessment/Baseline: Visit 2
Secondary	Stroke Aphasia Quality of Life (SA-QOL)	Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better	Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment
Secondary	Stroke Aphasia Quality of Life (SA-QOL)	Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better	Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment
Secondary	Stroke Aphasia Quality of Life (SA-QOL)	Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better	Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline