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tDCS Effects on Brain Plasticity in Aphasia Treatment

Primary Purpose

Aphasia, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Real tDCS
Sham tDCS
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring tDCS, MRI, Aphasia, Stroke, Speech therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real tDCS

Sham tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Picture naming
Picture-naming accuracy and response time for each stimuli will be determined perceptual and calculated using praat software

Secondary Outcome Measures

Imaging analysis
Mapping changes in functional connections of language networks, inter-hemispheric and intra-hemispheric regions of the brain.

Full Information

First Posted
July 29, 2022
Last Updated
August 8, 2022
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05483556
Brief Title
tDCS Effects on Brain Plasticity in Aphasia Treatment
Official Title
Brain Network Plasticity in Aphasic Patients Associated With Combined Speech Therapy and Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
tDCS, MRI, Aphasia, Stroke, Speech therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double (participant, outcome accessor)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real tDCS
Arm Type
Experimental
Arm Description
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
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Five participants will be allocated by the flip coin method to the sham comparator group. Participants will receive the tDCS stimulation for the 30s
Intervention Type
Device
Intervention Name(s)
Real tDCS
Intervention Description
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
Intervention Name(s)
Sham tDCS
Intervention Description
An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the left inferior frontal gyrus during speech therapy.
Primary Outcome Measure Information:
Title
Picture naming
Description
Picture-naming accuracy and response time for each stimuli will be determined perceptual and calculated using praat software
Time Frame
Change before, immediately after and two months after the treatment
Secondary Outcome Measure Information:
Title
Imaging analysis
Description
Mapping changes in functional connections of language networks, inter-hemispheric and intra-hemispheric regions of the brain.
Time Frame
Change before, immediately after and two months after the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Ney WONG, PhD
Phone
(852) 27667268
Email
min.wong@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Faisal N Baig, PhD
Phone
(852) 27666561
Email
faisal.n.baig@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Ney Wong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Ney Wong, PhD
Phone
(852) 2766 7268
Email
min.wong@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Faisal N Baig, PhD
Phone
(852) 27665651
Email
faisal.n.baig@polyu.edu.hk

12. IPD Sharing Statement

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tDCS Effects on Brain Plasticity in Aphasia Treatment

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