AphasiaNCT05483556
tDCS Effects on Brain Plasticity in Aphasia Treatment
A study testing Real tDCS in people with Aphasia and Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Real tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2021to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Kowloon
Min Ney Wong, PhD, (852) 2766 7268, min.wong@polyu.edu.hk
Faisal N Baig, PhD, (852) 27665651, faisal.n.baig@polyu.edu.hk
About this study
Official title: Brain Network Plasticity in Aphasic Patients Associated With Combined Speech Therapy and Transcranial Direct Current Stimulation
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.
Read the 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.
- Being tested
- Real tDCS, Sham tDCS
- Keywords
- tDCS, MRI, Aphasia, Stroke, Speech therapy
- Medical subject headings
- Aphasia, Stroke, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real tDCSDevice
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 tDCSDevice
An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the left inferior frontal gyrus during speech therapy.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Experimental | 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 Receives: Device: Real tDCS |
| Sham tDCS | Sham comparator | Five participants will be allocated by the flip coin method to the sham comparator group. Participants will receive the tDCS stimulation for the 30s Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Picture naming
Picture-naming accuracy and response time for each stimuli will be determined perceptual and calculated using praat software
Measured: Change before, immediately after and two months after the treatment
Secondary outcomes (1)
Imaging analysis
Mapping changes in functional connections of language networks, inter-hemispheric and intra-hemispheric regions of the brain.
Measured: Change before, immediately after and two months after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Nov 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Min Wong, The Hong Kong Polytechnic University
- Investigators
- Min Ney Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483556
- Sponsor's protocol ID
- HSEARS20220211001
- Status last verified
- Jan 2024
- First submitted
- 29 Jul 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Network Plasticity in Aphasic Patients Associated With Combined Speech Therapy and Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT05483556
- Acronym / sponsor ID
- HSEARS20220211001
- Keywords
- tDCS, MRI, Aphasia, Stroke, Speech therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Device: Real tDCSFive 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 |
| Sham tDCS | Sham comparator | Device: Sham tDCSFive participants will be allocated by the flip coin method to the sham comparator group. Participants will receive the tDCS stimulation for the 30s |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of a single unilateral left-hemispheric stroke,
- Right handedness
- Demonstrated features of Broca's Aphasia
- Cantonese speaker
- Comprehension sufficient to carry out tasks
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real tDCSAn anodal high-definition tDCS of 2 mA lasting for 20 minutes will be delivered to the left inferior frontal gyrus during speech therapy. | Device | Real tDCS |
| Sham tDCSAn anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the left inferior frontal gyrus during speech therapy. | Device | Sham tDCS |
Primary outcome
Picture naming
Time frame: 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
1 secondary outcome
Imaging analysis
Time frame: Change before, immediately after and two months after the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Ney Wong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real tDCS in people with Aphasia and Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Ney WONG, PhD ((852) 27667268, min.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Picture naming (time frame: Change before, immediately after and two months after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.