StrokePhase 1/2NCT02628561
Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke
A Phase 1/2 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 is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors. 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
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Apr 2016
- Phase
- Phase 1/2
- 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
- Age between 18 and 65 years
- Diagnosis of unilateral, non-recurring, subacute stroke
- Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it.
Who cannot join
- Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.
Read the detailed description
Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.
- Conditions
- Stroke, Cerebrovascular Disorders, Cerebral Infarction
- Being tested
- Transcranial direct current stimulation, Constraint-Induced Movement Therapy
- 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.
Transcranial direct current stimulationDevice
Constraint-Induced Movement TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Active tdcs/M1 | Active comparator | Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy) Receives: Device: Transcranial direct current stimulation; Behavioral: Constraint-Induced Movement Therapy |
| Active tdcs/Premotor | Experimental | Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy) Receives: Device: Transcranial direct current stimulation; Behavioral: Constraint-Induced Movement Therapy |
| Sham tdcs | Sham comparator | Sham tDCS and CIMT (constraint induced movement therapy) Receives: Device: Transcranial direct current stimulation; Behavioral: Constraint-Induced Movement Therapy |
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 baseline and week 2
Secondary outcomes (2)
Spasticity (Modified Ashworth Scale)
Measured: Baseline and Week 2
Muscle strength (Medical Research Council Scale)
Measured: Baseline and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionApr 2016
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
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
- NCT02628561
- Sponsor's protocol ID
- tdcstroke
- Status last verified
- Apr 2016
- First submitted
- 4 Dec 2015
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke
- ClinicalTrials.gov ID
- NCT02628561
- Acronym / sponsor ID
- tdcstroke
- Conditions
- Stroke, Cerebrovascular Disorders, Cerebral Infarction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Dec 2015 (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 is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.
Detailed description
Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active tdcs/M1 | Active comparator | Device: Transcranial direct current stimulation, Behavioral: Constraint-Induced Movement TherapyAnodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy) |
| Active tdcs/Premotor | Experimental | Device: Transcranial direct current stimulation, Behavioral: Constraint-Induced Movement TherapyAnodal tDCS on premotor cortex and CIMT (constraint induced movement therapy) |
| Sham tdcs | Sham comparator | Device: Transcranial direct current stimulation, Behavioral: Constraint-Induced Movement TherapySham tDCS and CIMT (constraint induced movement therapy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- Diagnosis of unilateral, non-recurring, subacute stroke
- Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it.
Key exclusion criteria (8 listed)
- Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits
- tDCS criteria:
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/M1, Active tdcs/Premotor, Sham tdcs |
| Constraint-Induced Movement Therapy | Behavioural | Active tdcs/M1, Active tdcs/Premotor, Sham tdcs |
Primary outcome
Functional Independence measured by Barthel Index
Time frame: Change for functional independence at baseline and week 2
2 secondary outcomes
Spasticity (Modified Ashworth Scale)
Time frame: Baseline and Week 2
Muscle strength (Medical Research Council Scale)
Time frame: Baseline and Week 2
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 5 Apr 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 3 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: finished, as of the sponsor's last update on 5 Apr 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional Independence measured by Barthel Index (time frame: Change for functional independence at baseline and week 2). 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 5 Apr 2016.