StrokePhase 3NCT05041582
SSRIs and TDCS Enhance Post-stroke Motor Recovery
A Phase 3 study testing tDCS, Citalopram and Rehabilitation in people with Stroke and Motor, run by Chih-Wei Tang.
Trial summary
Post-stroke motor recovery is compelling but limited. Current rehabilitation has less impacts on the plateau that spontaneous biological recovery could be expected. The advances in non-invasive neuromodulation and neurophysiological characterization of critical motor recovery period enable breaking the proportional… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- What is being tested?
- tDCS, Citalopram and Rehabilitation
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Aug 2025
- Phase
- Phase 3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 20-80;
- first-onset stroke
- brain image confirmed unilateral subcortical infarction
- moderate to severe upper-limb impairment (SAFE score <8).
- 3 days to 4 weeks after stroke onset
- stable medical condition
Who cannot join
- metal implants, such as electrodes or pacemaker
- epilepsy history or active spikes from EEG recording
- major depression or taking psychoactive drugs
- alcoholism or drug abuse history
- combined with other severe neurological or psychiatric diagnoses
- pregnancy or breastfeeding;
- other contraindications to brain MRI, such as severe claustrophobia
- intolerance to electrical stimulation
About this study
Official title: Combining SSRIs and TDCS to Enhance Motor Recovery After Stroke
Post-stroke motor recovery is compelling but limited. Current rehabilitation has less impacts on the plateau that spontaneous biological recovery could be expected. The advances in non-invasive neuromodulation and neurophysiological characterization of critical motor recovery period enable breaking the proportional recovery limitation. Our pilot studies demonstrated the safety and responsiveness of combing dual transcranial direct current stimulation (tDCS) and motor training in subacute stroke patients. There is also strong evidence that selective serotonin reuptake inhibitors (SSRIs) can substantially increase the effects of tDCS and improve motor function after stroke, even in the absence of depression. This proposal aims to prove the potential of combining of tDCS and the commonly used SSRI citalopram to improve response to a daily motor training intervention in acute stroke patients (Co-STARS trial).
Read the detailed description
This is a randomized, double-blind, sham-controlled study in 80 patients with first-ever, unilateral, subcortical ischemic stroke 0.5-4 weeks after stroke onset with moderate to severe hemiparesis. Participants were randomized into four groups underwent either real dual tDCS [ipsilesional primary motor cortex (M1) anodal stimulation and contralesional M1 cathodal stimulation; 2 mA for 20 mins; 10 sessions within 2 weeks] with citalopram or placebo, or sham stimulation with citalopram or placebo. All will receive concurrent hospitalized intensive rehabilitation of 2 daily sessions of 90-minute physiotherapy. Action reach am test (ARAT), Fugl-Meyer Assessment (FMA), multimodality MRI and EEG will be measured at baseline and after 2 weeks' tDCS modulation. The primary outcome is the ARAT at 3 months after intervention. The combination of tDCS and a SSRI will be expected to improve response to motor training more effectively than either intervention alone. The enhanced responsiveness will be correlated or predicted by biomarkers from multimodality MRI or EEG.
- Being tested
- tDCS, Citalopram, Rehabilitation
- Keywords
- stroke, motor recovery, transcranial direct current stimulation, selective serotonin reuptake inhibitors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
dual tDCS with ipsilesional primary motor cortex (M1) anodal stimulation and contralesional M1 cathodal stimulation, 2 weeks after SSRI treatment
CitalopramDrug
total 3 months, since 2-4 weeks after stroke
RehabilitationBehavioural
hospitalized rehabilitation, 3 hours daily
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS + Citalopram + Rehabilitation | Experimental | * Real tDCS, 2 mA for 20 mins per session, 10 sessions within 2 weeks
* Citalopram 10mg oral intake daily for 3 months, since 2 weeks before tDCS Receives: Device: tDCS; Drug: Citalopram; Behavioral: Rehabilitation |
| Sham tDCS + Citalopram + Rehabilitation | Sham comparator | * Sham tDCS, ramped up over 10 seconds and then reduced to 0mA, 10 sessions within 2 weeks
* Citalopram 10mg oral intake daily for 3 months, since 2 weeks before tDCS Receives: Drug: Citalopram; Behavioral: Rehabilitation |
| Real tDCS + Placebo + Rehabilitation | Placebo comparator | * Real tDCS, 2 mA for 20 mins per session, 10 sessions within 2 weeks
* Placebo oral intake daily for 3 months, since 2 weeks before tDCS Receives: Device: tDCS; Behavioral: Rehabilitation |
| Sham tDCS + Placebo + Rehabilitation | Placebo comparator | * Sham tDCS, ramped up over 10 seconds and then reduced to 0mA, 10 sessions within 2 weeks
* Placebo oral intake daily for 3 months, since 2 weeks before tDCS Receives: Behavioral: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor scores 3 months after intervention
Motor scores include Action research arm test (0-66, higher scores mean a better outcome) and Fugl-Meyer Assessment (0-54, higher scores mean a better outcome)
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chih-Wei Tang
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, University of Oxford
- Responsible party
- Sponsor-investigator, Chih-Wei Tang, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041582
- Sponsor's protocol ID
- Co-STARS
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining SSRIs and TDCS to Enhance Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT05041582
- Acronym / sponsor ID
- Co-STARS
- Keywords
- stroke, motor recovery, transcranial direct current stimulation, selective serotonin reuptake inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chih-Wei TangUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, University of Oxford
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 13 Sep 2021 (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.
Post-stroke motor recovery is compelling but limited. Current rehabilitation has less impacts on the plateau that spontaneous biological recovery could be expected. The advances in non-invasive neuromodulation and neurophysiological characterization of critical motor recovery period enable breaking the proportional recovery limitation. Our pilot studies demonstrated the safety and responsiveness of combing dual transcranial direct current stimulation (tDCS) and motor training in subacute stroke patients. There is also strong evidence that selective serotonin reuptake inhibitors (SSRIs) can substantially increase the effects of tDCS and improve motor function after stroke, even in the absence of depression. This proposal aims to prove the potential of combining of tDCS and the commonly used SSRI citalopram to improve response to a daily motor training intervention in acute stroke patients (Co-STARS trial).
Detailed description
This is a randomized, double-blind, sham-controlled study in 80 patients with first-ever, unilateral, subcortical ischemic stroke 0.5-4 weeks after stroke onset with moderate to severe hemiparesis. Participants were randomized into four groups underwent either real dual tDCS [ipsilesional primary motor cortex (M1) anodal stimulation and contralesional M1 cathodal stimulation; 2 mA for 20 mins; 10 sessions within 2 weeks] with citalopram or placebo, or sham stimulation with citalopram or placebo. All will receive concurrent hospitalized intensive rehabilitation of 2 daily sessions of 90-minute physiotherapy. Action reach am test (ARAT), Fugl-Meyer Assessment (FMA), multimodality MRI and EEG will be measured at baseline and after 2 weeks' tDCS modulation. The primary outcome is the ARAT at 3 months after intervention. The combination of tDCS and a SSRI will be expected to improve response to motor training more effectively than either intervention alone. The enhanced responsiveness will be correlated or predicted by biomarkers from multimodality MRI or EEG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Real tDCS + Citalopram + Rehabilitation | Experimental | Device: tDCS, Drug: Citalopram, Behavioral: Rehabilitation* Real tDCS, 2 mA for 20 mins per session, 10 sessions within 2 weeks * Citalopram 10mg oral intake daily for 3 months, since 2 weeks before tDCS |
| Sham tDCS + Citalopram + Rehabilitation | Sham comparator | Drug: Citalopram, Behavioral: Rehabilitation* Sham tDCS, ramped up over 10 seconds and then reduced to 0mA, 10 sessions within 2 weeks * Citalopram 10mg oral intake daily for 3 months, since 2 weeks before tDCS |
| Real tDCS + Placebo + Rehabilitation | Placebo comparator | Device: tDCS, Behavioral: Rehabilitation* Real tDCS, 2 mA for 20 mins per session, 10 sessions within 2 weeks * Placebo oral intake daily for 3 months, since 2 weeks before tDCS |
| Sham tDCS + Placebo + Rehabilitation | Placebo comparator | Behavioral: Rehabilitation* Sham tDCS, ramped up over 10 seconds and then reduced to 0mA, 10 sessions within 2 weeks * Placebo oral intake daily for 3 months, since 2 weeks before tDCS |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 20-80;
- first-onset stroke
- brain image confirmed unilateral subcortical infarction
- moderate to severe upper-limb impairment (SAFE score <8).
- 3 days to 4 weeks after stroke onset
Key exclusion criteria (8 listed)
- metal implants, such as electrodes or pacemaker
- epilepsy history or active spikes from EEG recording
- major depression or taking psychoactive drugs
- alcoholism or drug abuse history
- combined with other severe neurological or psychiatric diagnoses
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 |
|---|---|---|
| tDCSdual tDCS with ipsilesional primary motor cortex (M1) anodal stimulation and contralesional M1 cathodal stimulation, 2 weeks after SSRI treatment | Device | Real tDCS + Citalopram + Rehabilitation, Real tDCS + Placebo + Rehabilitation |
| Citalopramtotal 3 months, since 2-4 weeks after stroke | Drug | Real tDCS + Citalopram + Rehabilitation, Sham tDCS + Citalopram + Rehabilitation |
| Rehabilitationhospitalized rehabilitation, 3 hours daily | Behavioural | Real tDCS + Citalopram + Rehabilitation, Real tDCS + Placebo + Rehabilitation, Sham tDCS + Citalopram + Rehabilitation, Sham tDCS + Placebo + Rehabilitation |
Primary outcome
Motor scores 3 months after intervention
Time frame: 3 months after intervention
Motor scores include Action research arm test (0-66, higher scores mean a better outcome) and Fugl-Meyer Assessment (0-54, higher scores mean a better outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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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. 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 Phase 3 study testing tDCS, Citalopram and Rehabilitation in people with Stroke and Motor, run by Chih-Wei Tang.
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 8 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 13 Sep 2021. 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.
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?
Results are not available in the source record.
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?
Motor scores 3 months after intervention (time frame: 3 months after intervention). 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 13 Sep 2021.