tDCS Effects on Brain Plasticity in Aphasia Treatment

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05483556

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aphasia Stroke	Device: Real tDCS Device: Sham tDCS	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Double (participant, outcome accessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Real tDCS Five post-stroke patients will be allocated by the flip the coin method to the experimental group. Participants will receive anodal tDCS stimulation for 20 minutes	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 Comparator: Sham tDCS Five participants will be allocated by the flip coin method to the sham comparator group. Participants will receive the tDCS stimulation for the 30s	Device: 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.

Arm

Intervention/Treatment

Experimental: Real tDCS

Five post-stroke patients will be allocated by the flip the coin method to the experimental group. Participants will receive anodal tDCS stimulation for 20 minutes

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 Comparator: Sham tDCS

Five participants will be allocated by the flip coin method to the sham comparator group. Participants will receive the tDCS stimulation for the 30s

Device: 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.

Outcome Measures

Primary Outcome Measures

Picture naming [Change before, immediately after and two months after the treatment]
Picture-naming accuracy and response time for each stimuli will be determined perceptual and calculated using praat software

Secondary Outcome Measures

Imaging analysis [Change before, immediately after and two months after the treatment.]
Mapping changes in functional connections of language networks, inter-hemispheric and intra-hemispheric regions of the brain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

History of a single unilateral left-hemispheric stroke,
Right handedness
Demonstrated features of Broca's Aphasia
Cantonese speaker
Comprehension sufficient to carry out tasks
No history of other neurological diseases

Exclusion Criteria:

Aphasia due to reasons other than Stroke, Traumatic brain injury
Bilateral or multiple brain lesions
Wernicke's aphasia and other speech disorders, degenerative, psychiatric or metabolic disorders
Deaf, blind, pregnant/ or preparing for pregnancy, cognitive issues, tattoos
Have cochlear implants, pacemaker, surgical nails for bone fracture, artificial joints, dental braces, dentures
Taking anti-depressant medications