tDCS Effects on Brain Plasticity in Aphasia Treatment

NCT ID: NCT05483556

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aphasia Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double (participant, outcome accessor)

Study Groups

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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

Group Type EXPERIMENTAL

Real tDCS

Intervention Type DEVICE

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

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

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the left inferior frontal gyrus during speech therapy.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Min Wong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Ney Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Kowloon, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Min Ney WONG, PhD

Role: CONTACT

(852) 27667268

Faisal N Baig, PhD

Role: CONTACT

(852) 27666561

Facility Contacts

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Min Ney Wong, PhD

Role: primary

(852) 2766 7268

Faisal N Baig, PhD

Role: backup

(852) 27665651

Other Identifiers

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HSEARS20220211001

Identifier Type: -

Identifier Source: org_study_id

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