tDCS Effects on Brain Plasticity in Aphasia Treatment

Stroke Clinical Trial

Official title:

Brain Network Plasticity in Aphasic Patients Associated With Combined Speech Therapy and Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483556
• Other study ID #: HSEARS20220211001
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: The Hong Kong Polytechnic University
• Contact: Min Ney WONG, PhD
• Phone: (852) 27667268
• Email: min.wong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy of conventional speech therapy alone for aphasia recovery is inconclusive. The prospective study will monitor the effects of combined language therapy and tDCS through structural and functional MRI.

Description:

The efficacy of conventional speech therapy alone for aphasia recovery is inconclusive. The prospective study will monitor the effects of combined language therapy and tDCS through structural and functional MRI.

This randomized, placebo-controlled, double-blinded pilot study will recruit ten chronic stroke patients with Broca's Aphasia randomly assigned either to sham or an anodal tDCS groups. Following speech and language assessment, all the participants will receive 20 minutes of individualized language therapy daily for ten days in two consecutive weeks. Simultaneously, the treatment group will receive 20 minutes of 2mA anodal HD-tDCS over the left IFG, while the sham group will receive the 30s of 2mA anodal HD-tDCS. Structural, resting state and task activated functional MRI will be performed. Data acquisition will be performed before, immediately after and two months after the treatment.

Repeated measure ANOVA for changes in picture-naming accuracy and response time will be performed as a within-subject factor between sham and anodal tDCS. Pearson's correlation coefficient of left IFG and its homolog in the right hemisphere through Independent component analysis (ICA) of low-frequency fluctuations in resting-state and task activated state will be compared for functional connectivity analysis for IFG and other major languages hubs for oral language production between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. History of a single unilateral left-hemispheric stroke,

2. Right handedness

3. Demonstrated features of Broca's Aphasia

4. Cantonese speaker

5. Comprehension sufficient to carry out tasks

6. No history of other neurological diseases

Exclusion Criteria:

1. Aphasia due to reasons other than Stroke, Traumatic brain injury

2. Bilateral or multiple brain lesions

3. Wernicke's aphasia and other speech disorders, degenerative, psychiatric or metabolic disorders

4. Deaf, blind, pregnant/ or preparing for pregnancy, cognitive issues, tattoos

5. Have cochlear implants, pacemaker, surgical nails for bone fracture, artificial joints, dental braces, dentures

6. Taking anti-depressant medications

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• Real tDCS
An anodal high-definition tDCS of 2 mA lasting for 20 minutes will be delivered to the left inferior frontal gyrus during speech therapy.
• Sham tDCS
An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the left inferior frontal gyrus during speech therapy.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Picture naming	Picture-naming accuracy and response time for each stimuli will be determined perceptual and calculated using praat software	Change before, immediately after and two months after the treatment
Secondary	Imaging analysis	Mapping changes in functional connections of language networks, inter-hemispheric and intra-hemispheric regions of the brain.	Change before, immediately after and two months after the treatment.