AphasiaNCT05471570
Effect of Anodal Transcranial Direct Current Stimulation (tDCS) Over the Right-hemisphere on Picture Naming in Chronic Aphasia
A study testing tDCS stimulation in people with Aphasia, run by The University of Hong Kong.
Trial summary
There are two opposing hypotheses, namely the interference and laterality-shift hypotheses, regarding the role of the right hemisphere (RH) in language recovery following a left hemisphere damage. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Aphasia
- What is being tested?
- tDCS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 20 Dec 2017
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with chronic aphasia following the stroke
Who cannot join
- history of seizure or epilepsy,
- previous adverse reactions to TMS/tDCS,
- having a pace-maker or a metal implanted in the brain
- being pregnant
About this study
Official title: The Effect of tDCS Stimulation of Right Inferior Frontal Gyrus on Language Recovery in Speakers With Aphasia
There are two opposing hypotheses, namely the interference and laterality-shift hypotheses, regarding the role of the right hemisphere (RH) in language recovery following a left hemisphere damage. Transcranial direct current stimulation (tDCS) has received increasing attention as a potential complement to behavioural therapy.
This preliminary study aimed to examine the effect of excitatory (anodal) stimulation of right inferior frontal gyrus (IFG) on naming abilities of chronic people with aphasia (PWA) to examine the compensatory versus interference role of RH in language recovery, and to confirm the application of tDCS does not induce adverse effects on other cognitive and language functions.
- Conditions
- Aphasia
- Being tested
- tDCS stimulation
- Keywords
- tDCS, Aphasia, naming
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS stimulationDevice
Also called language therapy
The study examines the effect of excitatory stimulation of right inferior frontal gyrus (IFG) on naming abilities of people with aphasia (PWA) as compared to sham stimulation to examine the compensatory versus interference role of right hemisphere in language recovery after stroke.
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS | Active comparator | 20 minutes of one mA anodal High-Definition tDCS (HD-tDCS) over right IFG combined with 40 minutes of naming therapy for five consecutive days in week 1 Receives: Device: tDCS stimulation |
| sham tDCS | Sham comparator | 20-minutes sham HD-tDCS with 40-minutes therapy of naming therapy for five consecutive days in week 1 Receives: Device: tDCS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Picture naming task
One hundred and sixty pictures of concrete nouns from the Snodgrass and Vanderwart (1980) picture set (colored version) were utilised to measure the percentage of object naming accuracy. In particular, these pictures were divided into Set A (training targets) and Set B (untrained generalization targets), with eighty stimuli in each set.
Measured: Immediately after the end of each treatment session and block
Secondary outcomes (2)
language task
- Overall language skills are measured through the overall aphasia scores provided by the Cantonese version of Western Aphasia Battery (short-form).
The scale is called Aphasia quotient: Minimum value = 0, maximum value = 100, with higher scores mean a better performance.
Measured: Immediately after the end of each treatment block
Cognitive task
The cognitive skills are measured through the subtest scores provided by Oxford Cognitive Screening-Cantonese. The test uses different sub-tests including the Picture naming, Semantics, Orientation, Visual field task, Sentence reading , Calculation, Attention, Praxis, Memory, and Executive tasks. The range of values varies across the subtests. For all subtests except the executive task, the higher scores reflect better performance. For executive tasks the lower scores reflect better performance.
Measured: Immediately after the end of each treatment block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Jan 2017
- Primary completion1 Nov 2017
- Study completion20 Dec 2017
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 University of Hong KongThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Bakhtiar, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471570
- Sponsor's protocol ID
- tDCSAphasia
- Status last verified
- Nov 2022
- First submitted
- 18 Jul 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of tDCS Stimulation of Right Inferior Frontal Gyrus on Language Recovery in Speakers With Aphasia
- ClinicalTrials.gov ID
- NCT05471570
- Acronym / sponsor ID
- tDCSAphasia
- Conditions
- Aphasia
- Keywords
- tDCS, Aphasia, naming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 25 Jul 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.
There are two opposing hypotheses, namely the interference and laterality-shift hypotheses, regarding the role of the right hemisphere (RH) in language recovery following a left hemisphere damage. Transcranial direct current stimulation (tDCS) has received increasing attention as a potential complement to behavioural therapy.
This preliminary study aimed to examine the effect of excitatory (anodal) stimulation of right inferior frontal gyrus (IFG) on naming abilities of chronic people with aphasia (PWA) to examine the compensatory versus interference role of RH in language recovery, and to confirm the application of tDCS does not induce adverse effects on other cognitive and language functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS | Active comparator | Device: tDCS stimulation20 minutes of one mA anodal High-Definition tDCS (HD-tDCS) over right IFG combined with 40 minutes of naming therapy for five consecutive days in week 1 |
| sham tDCS | Sham comparator | Device: tDCS stimulation20-minutes sham HD-tDCS with 40-minutes therapy of naming therapy for five consecutive days in week 1 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People with chronic aphasia following the stroke
Key exclusion criteria (4 listed)
- history of seizure or epilepsy,
- previous adverse reactions to TMS/tDCS,
- having a pace-maker or a metal implanted in the brain
- being pregnant
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 |
|---|---|---|
| tDCS stimulationAlso: language therapyThe study examines the effect of excitatory stimulation of right inferior frontal gyrus (IFG) on naming abilities of people with aphasia (PWA) as compared to sham stimulation to examine the compensatory versus interference role of right hemisphere in language recovery after stroke. | Device | anodal tDCS, sham tDCS |
Primary outcome
Picture naming task
Time frame: Immediately after the end of each treatment session and block
One hundred and sixty pictures of concrete nouns from the Snodgrass and Vanderwart (1980) picture set (colored version) were utilised to measure the percentage of object naming accuracy. In particular, these pictures were divided into Set A (training targets) and Set B (untrained generalization targets), with eighty stimuli in each set.
2 secondary outcomes
language task
Time frame: Immediately after the end of each treatment block
Cognitive task
Time frame: Immediately after the end of each treatment block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Aphasia
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS stimulation in people with Aphasia, run by The University of 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Picture naming task (time frame: Immediately after the end of each treatment session and block). 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 4 Nov 2022.