Acute Ischemic Cerebrovascular DiseasePhase 3NCT07496645
EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE
A Phase 3 study testing Transcranial Direct Current Stimulation in people with Acute Ischemic Cerebrovascular Disease and Post Stroke Aphasia, run by Dr. Ram Manohar Lohia Hospital at 1 site in India.
Trial summary
The use of transcranial direct current stimulation (tDCS) for the management of deficits developed in stroke is a relatively new type of management option. Many of the studies performed using tDCS have focused on improvements noted in hemiplegia as compared to aphasia, which is an equally disabling outcome of strokes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Ischemic Cerebrovascular Disease, Post Stroke Aphasia, Aphasia Following Cerebral Infarction
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- 31 Mar 2026to 30 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Aphasic patients with left middle cerebral artery territory Acute Ischemic Stroke
- Patients between 18-65 years of age.
- Within 5 days of onset of stroke.
Who cannot join
- Patients with malignant Middle Cerebral Artery territory infarcts and previous clinical history of cerebral hemisphere stroke.
- Patients with history of previous brain surgery or skull defect due to surgery e.g. craniectomy.
- Patients with epilepsy.
- Patients with history of significant head trauma in the last 1 month.
- Patients with documented history of major depression prior to stroke.
- Patients with alcohol/drug abuse in the past 6 months.
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- Patients with prior significant cognitive impairment.
- Pacemaker in situ, cochlear implant in situ.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi
New Delhi, National Capital Territory of Delhi, 110001
Devavrata Kumar Duggal, Doctor (Professor), 08800815928, devsahu.90@gmail.com
Devavrata Sahu, Doctor, +918800815928, devsahu.90@gmail.com
About this study
The use of transcranial direct current stimulation (tDCS) for the management of deficits developed in stroke is a relatively new type of management option. Many of the studies performed using tDCS have focused on improvements noted in hemiplegia as compared to aphasia, which is an equally disabling outcome of strokes. The results of these studies have not been conclusive and concordant with each other.
In aphasia management, the majority of the studies have focused on chronic strokes. Since the use of tDCS is relatively new, the studies have not focused on a particular type of deficit or stroke. Very few studies have focused on the impact of solely using tDCS. Very few studies have focused on acute to subacute strokes. The results of the studies have, nevertheless, been encouraging.
Improvements in aspects of language tested after a single session of tDCS are short-lived. There is an unmet need to probe the utility of repetitive tDCS on aspects of language function in patients who are aphasic due to acute stroke. There is also a paucity of data in the Indian scenario regarding the same.
- Conditions
- Acute Ischemic Cerebrovascular Disease, Post Stroke Aphasia, Aphasia Following Cerebral Infarction, Aphasia, Acquired
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Transcranial Direct Current Stimulation, tDCS, Acute Ischemic Cerebrovascular Disease, Post stroke aphasia, Aphasia Following Cerebral Infarction
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Anodal tDCS
Transcranial Direct Current StimulationDevice
Sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS arm (will receive true tDCS) | Experimental | Will receive true Anodal tDCS Receives: Device: Transcranial Direct Current Stimulation |
| Sham tDCS arm (will receive Sham stimulation) | Sham comparator | Will receive Sham tDCS stimulation Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 5 days
Accuracy is defined as the number of words spoken without the help of a semantic or phonemic cue on the ICMR Picture Naming Test
Measured: at 5 days after tDCS
Co-Primary outcome: Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 5 days
Reaction times were documented in milliseconds.
Measured: at 5 days after tDCS
Secondary outcomes (6)
Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 5 days
Correct Response is defined as the total number of words spoken, with or without the help of either a semantic or a phonemic cue on the ICMR Picture Naming Test.
Measured: at 5 days after tDCS
Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 5 days
PNT scores are recorded as per the guidelines of the ICMR Picture Naming Test
Measured: at 5 days after tDCS
Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 4 weeks
Accuracy is defined as the number of words spoken without the help of a semantic or phonemic cue on the ICMR Picture Naming Test
Measured: at 4 weeks after tDCS
Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 4 weeks
Reaction times were documented in milliseconds.
Measured: at 4 weeks after tDCS
Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 4 weeks
Correct Response is defined as the total number of words spoken, with or without the help of either a semantic or a phonemic cue on the ICMR Picture Naming Test.
Measured: at 4 weeks after tDCS
Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 4 weeks
PNT scores are recorded as per the guidelines of the ICMR Picture Naming Test.
Measured: at 4 weeks after tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Cerebrovascular DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Ram Manohar Lohia Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Ashish Kumar Duggal, Dr. Ram Manohar Lohia Hospital
- Investigators
- Ashish Kumar Duggal, DM (Neurology), Principal investigator, Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496645
- Sponsor's protocol ID
- IEC/ABVIMS/RMLH/1093
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD collected throughout the trial will be available from the Principle Investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE
- ClinicalTrials.gov ID
- NCT07496645
- Acronym / sponsor ID
- IEC/ABVIMS/RMLH/1093
- Conditions
- Acute Ischemic Cerebrovascular Disease, Post Stroke Aphasia, Aphasia Following Cerebral Infarction, Aphasia, Acquired
- Keywords
- Transcranial Direct Current Stimulation, tDCS, Acute Ischemic Cerebrovascular Disease, Post stroke aphasia, Aphasia Following Cerebral Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Dr. Ram Manohar Lohia HospitalOther government
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Mar 2026 (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 use of transcranial direct current stimulation (tDCS) for the management of deficits developed in stroke is a relatively new type of management option. Many of the studies performed using tDCS have focused on improvements noted in hemiplegia as compared to aphasia, which is an equally disabling outcome of strokes. The results of these studies have not been conclusive and concordant with each other.
In aphasia management, the majority of the studies have focused on chronic strokes. Since the use of tDCS is relatively new, the studies have not focused on a particular type of deficit or stroke. Very few studies have focused on the impact of solely using tDCS. Very few studies have focused on acute to subacute strokes. The results of the studies have, nevertheless, been encouraging.
Improvements in aspects of language tested after a single session of tDCS are short-lived. There is an unmet need to probe the utility of repetitive tDCS on aspects of language function in patients who are aphasic due to acute stroke. There is also a paucity of data in the Indian scenario regarding the same.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS arm (will receive true tDCS) | Experimental | Device: Transcranial Direct Current StimulationWill receive true Anodal tDCS |
| Sham tDCS arm (will receive Sham stimulation) | Sham comparator | Device: Transcranial Direct Current StimulationWill receive Sham tDCS stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aphasic patients with left middle cerebral artery territory Acute Ischemic Stroke
- Patients between 18-65 years of age.
- Within 5 days of onset of stroke.
Key exclusion criteria (9 listed)
- Patients with malignant Middle Cerebral Artery territory infarcts and previous clinical history of cerebral hemisphere stroke.
- Patients with history of previous brain surgery or skull defect due to surgery e.g. craniectomy.
- Patients with epilepsy.
- Patients with history of significant head trauma in the last 1 month.
- Patients with documented history of major depression prior to stroke.
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 |
|---|---|---|
| Transcranial Direct Current StimulationAnodal tDCS | Device | Anodal tDCS arm (will receive true tDCS) |
| Transcranial Direct Current StimulationSham tDCS | Device | Sham tDCS arm (will receive Sham stimulation) |
Primary outcome
Primary Outcome: Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 5 days
Time frame: at 5 days after tDCS
Accuracy is defined as the number of words spoken without the help of a semantic or phonemic cue on the ICMR Picture Naming Test
Co-Primary outcome: Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 5 days
Time frame: at 5 days after tDCS
Reaction times were documented in milliseconds.
6 secondary outcomes
Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 5 days
Time frame: at 5 days after tDCS
Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 5 days
Time frame: at 5 days after tDCS
Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 4 weeks
Time frame: at 4 weeks after tDCS
Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 4 weeks
Time frame: at 4 weeks after tDCS
Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 4 weeks
Time frame: at 4 weeks after tDCS
Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 4 weeks
Time frame: at 4 weeks after tDCS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. IPD collected throughout the trial will be available from the Principle Investigator upon reasonable request.
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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.
Ashish Kumar Duggal, DM (Neurology) principal investigator
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcranial Direct Current Stimulation in people with Acute Ischemic Cerebrovascular Disease and Post Stroke Aphasia, run by Dr. Ram Manohar Lohia Hospital at 1 site in India.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 Mar 2026. 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 India. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashish Kumar Duggal, Doctor (Professor) (+919810523332, ashishduggal2005@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 5 days (time frame: at 5 days after tDCS). The study lists 2 primary outcomes in all. 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 27 Mar 2026.