Neuro Device for Aphasia

Post-stroke Aphasia Clinical Trial

Official title:

Neurostimulation for the Treatment of Post-Stroke Aphasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194566
• Other study ID #: STUDY-21-01577
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Aidan Rogers
• Phone: (718) 308-9450
• Email: aidan.rogers[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the trial is to determine whether 75Hz transcranial alternating current stimulation (tACS) synchronized with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia.

Description:

There are about 15 million strokes worldwide each year. Of this group, about 30% suffer from aphasia. Aphasia is a speech-language disorder associated with exceptional difficulty performing daily communication activities. If no improvement is observed within the first months after the stroke, a complete recovery is unlikely, and the therapy can last for years.

Up to date, speech and language therapy is a standard of care for post-stroke aphasia, however the process is long and demanding.

In the past, several clinical trials aimed to verify the efficacy of language training paired with transcranial direct current stimulation (tDCS), however recent meta-analysis indicates only possible effectiveness (Level C evidence) of anodal tDCS in chronic post-stroke aphasia.

To boost the effects of aphasia rehabilitation, effective brain stimulation protocol still needs to be developed.

Transcranial alternating current stimulation (tACS) can be an interesting alternative to tDCS, as it is able to influence cortical excitability and activity.

Stimulation within high gamma oscillations (60-500Hz) might allow for better speech-language processing, as this band is considered to be the cognitive index of linguistic processes. Moreover, a short period of 75Hz tACS over the motor cortex suggested the positive impact of high-gamma tACS on brain plasticity.

The aim of this RCT is to determine whether 75Hz transcranial alternating current stimulation (tACS) paired with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia, measured as an ability to name trained items at 12 weeks follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Individuals with aphasia (assessed using the Boston Diagnostic Aphasia Examination) who perform the Naming Task in the range of 10%-60% accuracy will be included in the study. The overall baseline score in the Naming Task will be estimated from the two baseline measurements.

Inclusion Criteria:

• diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist).

• presence of a focus of injury in the left hemisphere (within one hemisphere only) as a result of the first ischemic or hemorrhagic stroke (based on CT/MRI examination);

• chronic stage of the disease - time since the stroke occurred over 6 months.

• ability to achieve an accuracy in the Naming Task of 10-60%.

• 18-80 years

• right-handedness before the stroke.

• ability to give informed written consent.

• fluency in English.

Exclusion Criteria:

• severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command.

• presence of metal implants in the skull.

• presence of major untreated or unstable psychiatric disease.

• history of epilepsy or seizures.

• ongoing medication that increases the risk of epileptic seizures.

• presence in the body of cardiac stimulators or pacemaker.

• history of speech, language, hearing, or intellectual disability during childhood.

• pregnancy (based on declarations)

Exclusion criteria during the trial:

• high intolerance to stimulation.

• occurrence of an epileptic seizure.

• other previously absent neurological or mental symptoms

Withdrawal criteria:

• high intolerance to stimulation (participants experience severe discomfort during stimulation);

• occurrence of an epileptic seizure;

• other previously absent neurological, physical or mental symptoms.

Related Conditions & MeSH terms

• Aphasia
• Post-stroke Aphasia

Intervention

Device:
• tACS
Neurostimulation will be done using the Neuro Device tCS (Neuro Device tCS), which is a certified transcranial electrical stimulator. The device consists of a stimulator with a touch screen, two electrodes and a soft, flexible cap to ensure stability of the electrodes on the head.

Locations

Country	Name	City	State
United States	Abilities Research Center at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Neuro Device Group S.A.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fridriksson J, Elm J, Stark BC, Basilakos A, Rorden C, Sen S, George MS, Gottfried M, Bonilha L. BDNF genotype and tDCS interaction in aphasia treatment. Brain Stimul. 2018 Nov-Dec;11(6):1276-1281. doi: 10.1016/j.brs.2018.08.009. Epub 2018 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage score in the Naming Task (trained words)	The Baseline Naming Task consists of 344 images representing nouns and the images will be presented on the computer screen. The task is to name the presented noun by producing the name of the item out loud. The answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items marked with a score of 3 are considered accurate. From the baseline assessment, a random list of 50 incorrectly named words will be trained in therapy. Minimum score is 0% (inability to name any objects) and maximum score is 100% (accuracy in naming all presented objects), where a higher score indicates a better health outcome	at 12 weeks
Secondary	Naming Task (untrained words)	Generalization - percentage score in the Naming Task (untrained words). The answer is scored on a three-stage scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Every Naming Task session will be recorded, so the independent SLP (speech-language pathologist) will again assess response accuracy. In case of inconsistency of scores, third independent SLP will decide.	at 12 weeks
Secondary	Naming reaction time (within baseline naming task)	Amount of time elapsed between the presentation of the stimuli to the first attempt of the patient's response. Measured by clinician recording of time elapsed before response attempted for each stimuli presented. Average overall response time will at baseline will be recorded.	at Baseline
Secondary	Naming reaction time (within baseline naming task)	Amount of time elapsed between the presentation of the stimuli to the first attempt of the patient's response. Measured by clinician recording of time elapsed before response attempted for each stimuli presented. Average overall response time at 12-week follow-up will be recorded.	at 12-week follow-up
Secondary	Number of correct answers without supporting cues	Number of correct answers on the fifth level (no cueing) during the therapy task. Greater number of correct responses indicates better response to treatment.	2 weeks
Secondary	Accuracy of naming during the therapy session	Number of correct responses to presented stimuli. Greater number of correct responses indicates better response to treatment.	2 weeks
Secondary	Percentage Score in Naming Task (untrained words)	Percentage score calculated for words not trained in therapy task to assess generalization. Patients are presented with 25 words not trained during therapy sessions. Each answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items receiving a score of 3 are marked as correct, with a maximum total number of correct items being 25. Minimum score is 0% (0/25- inability to name any objects) and maximum score is 100% (25/25- accuracy in naming all presented objects), where higher score indicates better response to treatment.	at Baseline
Secondary	Percentage Score in Naming Task (untrained words)	Percentage score calculated for words not trained in therapy task to assess generalization. Patients are presented with 25 words not trained during therapy sessions. Each answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items receiving a score of 3 are marked as correct, with a maximum total number of correct items being 25. Minimum score is 0% (0/25- inability to name any objects) and maximum score is 100% (25/25- accuracy in naming all presented objects), where higher score indicates better response to treatment.	at the end of the last therapy session at the end of week 4
Secondary	Percentage Score in Naming Task (untrained words)	Percentage score calculated for words not trained in therapy task to assess generalization. Patients are presented with 25 words not trained during therapy sessions. Each answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items receiving a score of 3 are marked as correct, with a maximum total number of correct items being 25. Minimum score is 0% (0/25- inability to name any objects) and maximum score is 100% (25/25- accuracy in naming all presented objects), where higher score indicates better response to treatment.	at 6-week follow-up
Secondary	Percentage Score in Naming Task (untrained words)	Percentage score calculated for words not trained in therapy task to assess generalization. Patients are presented with 25 words not trained during therapy sessions. Each answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items receiving a score of 3 are marked as correct, with a maximum total number of correct items being 25. Minimum score is 0% (0/25- inability to name any objects) and maximum score is 100% (25/25- accuracy in naming all presented objects), where higher score indicates better response to treatment.	at 12-week follow-up
Secondary	Communication Effectiveness Index (CETI)	The participants primary communication partner rates the participants' ability to perform in sixteen communication situations on a visual analog scale with the lowest value (a score of 0) as "not at all able" and the greatest value (a score of 10) as "as able to as before", where higher scores indicate better health outcomes.	at Baseline
Secondary	Communication Effectiveness Index (CETI)	The participants primary communication partner rates the participants' ability to perform in sixteen communication situations on a visual analog scale with the lowest value (a score of 0) as "not at all able" and the greatest value (a score of 10) as "as able to as before", where higher scores indicate better health outcomes.	at the end of the last therapy session at the end of week 4
Secondary	Communication Effectiveness Index (CETI)	The participants primary communication partner rates the participants' ability to perform in sixteen communication situations on a visual analog scale with the lowest value (a score of 0) as "not at all able" and the greatest value (a score of 10) as "as able to as before", where higher scores indicate better health outcomes.	at 6-week follow-up
Secondary	Communication Effectiveness Index (CETI)	The participants primary communication partner rates the participants' ability to perform in sixteen communication situations on a visual analog scale with the lowest value (a score of 0) as "not at all able" and the greatest value (a score of 10) as "as able to as before", where higher scores indicate better health outcomes.	at 12-week follow-up
Secondary	Boston Diagnostic Aphasia Examination (BDAE)	Oral Expression Subtest - the speech language pathologist assesses the patient with the oral expression portion of the BDAE. Areas assessed include automatic sequences, repetition of words and sentences, responsive and confrontational naming, and screening of letters and numbers. Each item receives a point for correctness with a maximal score of 48	at Baseline
Secondary	Boston Diagnostic Aphasia Examination (BDAE)	Oral Expression Subtest - the speech language pathologist assesses the patient with the oral expression portion of the BDAE. Areas assessed include automatic sequences, repetition of words and sentences, responsive and confrontational naming, and screening of letters and numbers. Each item receives a point for correctness with a maximal score of 48	at 12-week follow-up
Secondary	Accuracy of masking measurement: Patient and Researcher	The opinion of the patient and of the researcher on receiving the placebo vs. active stimulation. The patient and researcher provide their guess/opinion as to whether the stimulation received during treatment was active or sham. It will be taken after the end of the last treatment session.	end of treatment (at 12 weeks)
Secondary	Visual Analog Scale (VAS)	Stimulation tolerance/side effects are measured using a visual analog scale with seven components (headache, fatigue, sleepiness, dizziness, pain on scalp, tingling on scalp, burning sensation on scalp, and itching on scalp). Ratings will be taken before and after each session. Full scale 0-10 per component. Higher score indicates a higher degree of each side effect.	2 weeks
Secondary	Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score	Assesses the ability to complete daily tasks pertaining to self-care, communication, interaction with others, and physical mobility. The SAQOL includes 17 questions, where questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Total score ranges from 17-85. Scores are averaged across three domains (physical, communication, and psychosocial), with lower scores indicating lesser ability (lower quality of life) and higher scores indicating great ability or independence (greater quality of life)	at Baseline
Secondary	Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score	Assesses the ability to complete daily tasks pertaining to self-care, communication, interaction with others, and physical mobility. The SAQOL includes 17 questions, where questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Total score ranges from 17-85. Scores are averaged across three domains (physical, communication, and psychosocial), with lower scores indicating lesser ability (lower quality of life) and higher scores indicating great ability or independence (greater quality of life)	at the end of the last therapy session at the end of week 4
Secondary	Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score	Assesses the ability to complete daily tasks pertaining to self-care, communication, interaction with others, and physical mobility. The SAQOL includes 17 questions, where questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Total score ranges from 17-85. Scores are averaged across three domains (physical, communication, and psychosocial), with lower scores indicating lesser ability (lower quality of life) and higher scores indicating great ability or independence (greater quality of life)	at 6-week follow-up
Secondary	Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score	Assesses the ability to complete daily tasks pertaining to self-care, communication, interaction with others, and physical mobility. The SAQOL includes 17 questions, where questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Total score ranges from 17-85. Scores are averaged across three domains (physical, communication, and psychosocial), with lower scores indicating lesser ability (lower quality of life) and higher scores indicating great ability or independence (greater quality of life)	at 12-week follow-up
Secondary	General Health Questionnaire (GHQ-12)	Identifies minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients. GHQ-12 is a 12-items scaled version that assesses somatic symptoms, anxiety, and insomnia, social dysfunction, and severe depression. A total score ranges from 0 to 36, with higher scores indicating worse conditions	at Baseline
Secondary	General Health Questionnaire (GHQ-12)	Identifies minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients. GHQ-12 is a 12-items scaled version that assesses somatic symptoms, anxiety, and insomnia, social dysfunction, and severe depression. A total score ranges from 0 to 36, with higher scores indicating worse conditions	at the end of the last therapy session at the end of week 4
Secondary	General Health Questionnaire (GHQ-12)	Identifies minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients. GHQ-12 is a 12-items scaled version that assesses somatic symptoms, anxiety, and insomnia, social dysfunction, and severe depression. A total score ranges from 0 to 36, with higher scores indicating worse conditions	at 6-week follow-up
Secondary	General Health Questionnaire (GHQ-12)	Identifies minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients. GHQ-12 is a 12-items scaled version that assesses somatic symptoms, anxiety, and insomnia, social dysfunction, and severe depression. A total score ranges from 0 to 36, with higher scores indicating worse conditions	at 12-week follow-up
Secondary	Brief Resilience Scale (BRS)	Assesses the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience). Higher scores indicate better health outcomes.	at Baseline
Secondary	Brief Resilience Scale (BRS)	Assesses the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience). Higher scores indicate better health outcomes.	at the end of the last therapy session at the end of week 4
Secondary	Brief Resilience Scale (BRS)	Assesses the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience). Higher scores indicate better health outcomes.	at 6-week follow-up
Secondary	Brief Resilience Scale (BRS)	Assesses the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience). Higher scores indicate better health outcomes.	at 12-week follow-up
Secondary	BDNF genotype	Saliva samples will be collected to test for typical vs. atypical brain plasticity biomarkers, as BDNF genotype may interfere with results of therapy paired with transcranial electrical stimulation. Research suggests that individuals with an atypical BDNF genotype are less receptive to the beneficial effects of speech-language therapy paired with anodal transcranial direct current stimulation, compared to individuals with typical BDNF genotype	at Baseline