Cerebrovascular AccidentNCT00542256
tDCS and Physical Therapy in Stroke
A study testing Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy in people with Cerebrovascular Accident, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to 10 Nov 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed)
- Demonstrates adequate balance while wearing a hand restraint on the unaffected arm
- Ability to stand from a sitting position and ability to stand with or without upper extremity support
- Stroke onset at least 6 months prior to study enrollment
Who cannot join
- Significant pre-stroke disability
- Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
- Excessive pain in any joint of the paretic extremity
- A terminal medical diagnosis consistent with survival of less than 1 year
- Advanced liver, kidney, cardiac, or pulmonary disease
- Coexistent major neurological or psychiatric disease (including epilepsy)
Show all 10Show fewer
- A history of significant alcohol or drug abuse in the prior 3 years
- Use of neuropsychotropic drugs - such as antidepressants
- Patients may not be actively enrolled in a separate intervention study targeting stroke recovery
- Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.
We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.
- Conditions
- Cerebrovascular Accident
- Being tested
- Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy, Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy
- Keywords
- Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke, CVA (Cerebrovascular Accident), Stroke, Stroke, Acute, Vascular Accident, Brain
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial Direct Current Stimulation / Constraint Induced Movement TherapyDevice
14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.
Sham transcranial Direct Current Stimulation / Constraint Induced Movement TherapyDevice
14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each of the 10 weekday training sessions, participants will receive 40 minutes of active tDCS over the primary motor cortex. Receives: Device: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy |
| 2 | Sham comparator | Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex. Receives: Device: Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen-Taylor Hand Function Test
Measured: Baseline, Treatment days 1,5,10, Follow Up
Motor Activity Log Rating Scale
Measured: Baseline, Treatment Days 1,5,10 and Follow Up
Beck Depression Inventory
Measured: Baseline, Treatment days 1,5,10 and Follow up
Visual Analogue Scale for Anxiety
Measured: Baseline, Treatment days 1,5,10 and Follow Up
Secondary outcomes (3)
Fugl Meyer Assessment of Motor Recovery
Measured: Baseline Assessment
Barthel Index Score
Measured: Baseline Assessment
Modified Ashworth Scale
Measured: Baseline Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startSep 2007
- Primary completion10 Nov 2014
- Study completion10 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Fregni, Beth Israel Deaconess Medical Center
- Investigators
- Felipe Fregni, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542256
- Sponsor's protocol ID
- 2007P000420
- Status last verified
- Mar 2017
- First submitted
- 10 Oct 2007
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 33175411
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT00542256
- Acronym / sponsor ID
- 2007P000420
- Conditions
- Cerebrovascular Accident
- Keywords
- Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke, CVA (Cerebrovascular Accident), Stroke, Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- 10 Nov 2014 (actual)
- Study completion
- 10 Nov 2014 (actual)
- First posted
- 11 Oct 2007 (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 a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.
We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Active transcranial Direct Current Stimulation / Constraint Induced Movement TherapyEach subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each of the 10 weekday training sessions, participants will receive 40 minutes of active tDCS over the primary motor cortex. |
| 2 | Sham comparator | Device: Sham transcranial Direct Current Stimulation / Constraint Induced Movement TherapyEach subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed)
- Demonstrates adequate balance while wearing a hand restraint on the unaffected arm
- Ability to stand from a sitting position and ability to stand with or without upper extremity support
- Stroke onset at least 6 months prior to study enrollment
Key exclusion criteria (10 listed)
- Significant pre-stroke disability
- Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
- Excessive pain in any joint of the paretic extremity
- A terminal medical diagnosis consistent with survival of less than 1 year
- Advanced liver, kidney, cardiac, or pulmonary disease
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 |
|---|---|---|
| Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes. | Device | 1 |
| Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds. | Device | 2 |
Primary outcome
Jebsen-Taylor Hand Function Test
Time frame: Baseline, Treatment days 1,5,10, Follow Up
Motor Activity Log Rating Scale
Time frame: Baseline, Treatment Days 1,5,10 and Follow Up
Beck Depression Inventory
Time frame: Baseline, Treatment days 1,5,10 and Follow up
Visual Analogue Scale for Anxiety
Time frame: Baseline, Treatment days 1,5,10 and Follow Up
3 secondary outcomes
Fugl Meyer Assessment of Motor Recovery
Time frame: Baseline Assessment
Barthel Index Score
Time frame: Baseline Assessment
Modified Ashworth Scale
Time frame: Baseline Assessment
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 21 Mar 2017.
- 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.
- Related InfoLink provided by the sponsor.
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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.
Felipe Fregni, MD, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy in people with Cerebrovascular Accident, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 4 inclusion and 10 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 21 Mar 2017. 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 United States. 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.
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?
Jebsen-Taylor Hand Function Test (time frame: Baseline, Treatment days 1,5,10, Follow Up). The study lists 4 primary outcomes in all. 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 NCT00542256, which also lists 1 linked publication.
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 21 Mar 2017.