StrokePhase 2/3START-tDCSNCT02156635
Stroke Treatment Associate to Rehabilitation Therapy and Transcranial DC Stimulation
A Phase 2/3 study testing Transcranial direct current stimulation and Constraint-Induced Movement Therapy in people with Stroke and Cerebrovascular Disorders, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Cerebral Infarction
- What is being tested?
- Transcranial direct current stimulation and Constraint-Induced Movement Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Jul 2017
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischaemic acute stroke
- Informed consent
Who cannot join
- 25 ≤ National Institute of Health Stroke Scale ≤ 32
- Rankim ≥ 5
- Mini Mental State Examination ≤ 24
- tDCS criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system CIMT criteria: inability to actively execute the movements of wrist flexion, metacarpophalangeal and interphalangeal active extension of 10º and wrist extension of 20º
Trial locations and contacts
1 site in 1 country.
Suellen Andrade contact
Brazil1 site
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraíba, 58051-900
Suellen Andrade, suellenandrade@gmail.com
Suellen Andrade
About this study
Official title: A Double-blind, Sham-controlled, Randomized Clinical Trial on Stroke Treatment Using Transcranial Direct Current Stimulation
The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke
Read the detailed description
Stroke is defined as an acute neurological dysfunction of vascular origin, with subtle development of clinical signs of cerebral function disturbs, lasting more than 24h. The traditional therapy includes drugs and physical rehabilitation, without systematization, with complicates its replication. The transcranial direct current (DC) stimulation might promote an increase in the motor function of the hands, when compared with placebo stimulation.
In fact, some clinical trials point positive effects of transcranial DC stimulation (tDCS) as a post-stroke intervention, however, in general, they only include patients in the chronic stage, with cerebral damage in different areas and diverse disabilities, most being assisted by non-standardized physical therapy treatments. tDCS combined with a standardized physiotherapy program, noted as constraint-induced movement therapy (CIMT), could be able to modulate the cortical excitability and promote better functional recovery.
However, no relate of longitudinal studies assessing patients in the acute stage submitted to tDCS and physiotherapy for more than 6 months have been found. Studies like this would help us elucidate the action mechanisms of this treatment in the early stages of stroke.
With this in mind, START - tDCS, a phase II/III clinical trial, will be developed to assess the therapeutic effects of the tDCS in early stage enrolling 40 post-stroke patients. They will be allocated in 2 groups at random to receive active tDCS or sham, associate to CIMT. The protocol will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed for 1 month. By the end of the study, the participants that receive tDCS and show better clinical condition will be invited to participate in bimonthly stimulation for 12 months, as part of a longitudinal study regarding tDCS for stroke. An increase in the clinical condition will be considered as a final score higher than 10 points in the Barthel Index, our primary outcome, when compared with baseline, before the treatment protocol.
- Conditions
- Stroke, Cerebrovascular Disorders, Cerebral Infarction
- Being tested
- Transcranial direct current stimulation, Constraint-Induced Movement Therapy, Placebo
- Keywords
- Rehabilitation, Direct Current Stimulation, Acute Stroke
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement TherapyBehavioural
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Active tdcs / CIMT | Experimental | Participants in the acute post-stroke stage will receive active tDCS associate to rehabilitation (CIMT) Receives: Device: Transcranial direct current stimulation; Behavioral: Constraint-Induced Movement Therapy |
| Sham stimulation / CIMT | Sham comparator | Participants in the acute post-stroke stage will receive sham stimulation associate to rehabilitation (CIMT) Receives: Behavioral: Constraint-Induced Movement Therapy; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence measured by Barthel Index
Measured: Change for functional independence at 4 months
Secondary outcomes (11)
Cognitive dysfunction (Montreal Cognitive Assessment)
Measured: Baseline (week 1) and Endpoint (week 4)
Executive functions (Victoria version of the Stroop Color and Word Test)
Measured: Baseline (week 1) and Endpoint (week 4)
Attention and Working Memory (Digit span subtest)
Measured: Baseline (week 1) and Endpoint (week 4)
Spasticity
Measured: Baseline, Week 2 and Week 4
Muscle strength
Measured: Baseline, Week 2 and Week 4
Balance
Measured: Baseline, Week 2 and Week 4
Posture
Measured: Baseline, Week 2 and Week 4
Fear of falling during daily life activities
Measured: Baseline, Week 2 and Week 4
Upper limb function
Measured: Baseline, Week 2 and Week 4
Quality of life
Measured: Baseline, Week 2 and Week 4
Lower limb function
Measured: Baseline, Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startFeb 2016
- Primary completionJun 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156635
- Sponsor's protocol ID
- TDCS 001
- Acronym
- START-tDCS
- Status last verified
- Dec 2015
- First submitted
- 26 May 2014
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411Andrade SM, Santos NA, Fernandez-Calvo B, Boggio PS, Oliveira EA, Ferreira JJ, Sobreira A, Morgan F, Medeiros G, Cavalcanti GS, Gadelha ID, Duarte J, Marrocos J, Silva MA, Rufino T, Nobrega SR. Stroke Treatment Associated with Rehabilitation Therapy and Transcranial DC Stimulation (START-tDCS): a study protocol for a randomized controlled trial. Trials. 2016 Jan 28;17:56. doi: 10.1186/s13063-016-1186-7.
PubMed 26822418
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Sham-controlled, Randomized Clinical Trial on Stroke Treatment Using Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT02156635
- Acronym / sponsor ID
- START-tDCS / TDCS 001
- Conditions
- Stroke, Cerebrovascular Disorders, Cerebral Infarction
- Keywords
- Rehabilitation, Direct Current Stimulation, Acute Stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 5 Jun 2014 (estimated)
- 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 purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke
Detailed description
Stroke is defined as an acute neurological dysfunction of vascular origin, with subtle development of clinical signs of cerebral function disturbs, lasting more than 24h. The traditional therapy includes drugs and physical rehabilitation, without systematization, with complicates its replication. The transcranial direct current (DC) stimulation might promote an increase in the motor function of the hands, when compared with placebo stimulation.
In fact, some clinical trials point positive effects of transcranial DC stimulation (tDCS) as a post-stroke intervention, however, in general, they only include patients in the chronic stage, with cerebral damage in different areas and diverse disabilities, most being assisted by non-standardized physical therapy treatments. tDCS combined with a standardized physiotherapy program, noted as constraint-induced movement therapy (CIMT), could be able to modulate the cortical excitability and promote better functional recovery.
However, no relate of longitudinal studies assessing patients in the acute stage submitted to tDCS and physiotherapy for more than 6 months have been found. Studies like this would help us elucidate the action mechanisms of this treatment in the early stages of stroke.
With this in mind, START - tDCS, a phase II/III clinical trial, will be developed to assess the therapeutic effects of the tDCS in early stage enrolling 40 post-stroke patients. They will be allocated in 2 groups at random to receive active tDCS or sham, associate to CIMT. The protocol will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed for 1 month. By the end of the study, the participants that receive tDCS and show better clinical condition will be invited to participate in bimonthly stimulation for 12 months, as part of a longitudinal study regarding tDCS for stroke. An increase in the clinical condition will be considered as a final score higher than 10 points in the Barthel Index, our primary outcome, when compared with baseline, before the treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tdcs / CIMT | Experimental | Device: Transcranial direct current stimulation, Behavioral: Constraint-Induced Movement TherapyParticipants in the acute post-stroke stage will receive active tDCS associate to rehabilitation (CIMT) |
| Sham stimulation / CIMT | Sham comparator | Behavioral: Constraint-Induced Movement Therapy, Other: PlaceboParticipants in the acute post-stroke stage will receive sham stimulation associate to rehabilitation (CIMT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischaemic acute stroke
- Informed consent
Key exclusion criteria (4 listed)
- 25 ≤ National Institute of Health Stroke Scale ≤ 32
- Rankim ≥ 5
- Mini Mental State Examination ≤ 24
- tDCS criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system CIMT criteria: inability to actively execute the movements of wrist flexion, metacarpophalangeal and interphalangeal active extension of 10º and wrist extension of 20º
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 stimulation | Device | Active tdcs / CIMT |
| Constraint-Induced Movement Therapy | Behavioural | Active tdcs / CIMT, Sham stimulation / CIMT |
| Placebo | Other | Sham stimulation / CIMT |
Primary outcome
Functional Independence measured by Barthel Index
Time frame: Change for functional independence at 4 months
11 secondary outcomes
Cognitive dysfunction (Montreal Cognitive Assessment)
Time frame: Baseline (week 1) and Endpoint (week 4)
Executive functions (Victoria version of the Stroop Color and Word Test)
Time frame: Baseline (week 1) and Endpoint (week 4)
Attention and Working Memory (Digit span subtest)
Time frame: Baseline (week 1) and Endpoint (week 4)
Spasticity
Time frame: Baseline, Week 2 and Week 4
Muscle strength
Time frame: Baseline, Week 2 and Week 4
Balance
Time frame: Baseline, Week 2 and Week 4
Posture
Time frame: Baseline, Week 2 and Week 4
Fear of falling during daily life activities
Time frame: Baseline, Week 2 and Week 4
Upper limb function
Time frame: Baseline, Week 2 and Week 4
Quality of life
Time frame: Baseline, Week 2 and Week 4
Lower limb function
Time frame: Baseline, Week 2 and Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
- Derived from this study: PubMed 26822418Andrade SM, Santos NA, Fernandez-Calvo B, Boggio PS, Oliveira EA, Ferreira JJ, Sobreira A, Morgan F, Medeiros G, Cavalcanti GS, Gadelha ID, Duarte J, Marrocos J, Silva MA, Rufino T, Nobrega SR. Stroke Treatment Associated with Rehabilitation Therapy and Transcranial DC Stimulation (START-tDCS): a study protocol for a randomized controlled trial. Trials. 2016 Jan 28;17:56. doi: 10.1186/s13063-016-1186-7.
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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.
Suellen Andrade contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Transcranial direct current stimulation and Constraint-Induced Movement Therapy in people with Stroke and Cerebrovascular Disorders, run by Federal University of Paraíba at 1 site in Brazil.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Dec 2015. 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 Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Suellen Andrade (suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence measured by Barthel Index (time frame: Change for functional independence at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156635, which also lists 2 linked publications.
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 7 Dec 2015.