StrokeTDCS+OTNCT00792428
Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery
A study testing Real Transcranial Direct Current Stimulation in people with Stroke and 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 non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebrovascular Accident, CVA
- What is being tested?
- Real Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to 1 Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First time clinical ischemic stroke or cerebrovascular accident
- At least 5 months out from first ischemic stroke prior to study enrollment
Who cannot join
- More than 1 stroke (older strokes)
- Significant pre-stroke disability
- A terminal medical illness or disorder with survival of less than 1 year
- Co-existent major neurological or psychiatric diseases (e.g., epilepsy)
- Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents
- Active participation in other stroke recovery trials testing interventions
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center / Harvard Medical School
Boston, Massachusetts, 02215
About this study
Official title: Facilitating Motor Recovery After Stroke Using tDCS
The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.
- Conditions
- Stroke, Cerebrovascular Accident, CVA, Acute Stroke, Acute Cerebrovascular Accident, Apoplexy
- Being tested
- Real Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
- Keywords
- Stroke, Ischemia, Infarction, Cerebrovascular Disorder, Central Nervous System Diseases, Brain Infarction, Brain Ischemia, Rehabilitation, Recovery, Neurorehabilitation, Plasticity
- Medical subject headings
- Stroke, Ischemia, Infarction, Cerebrovascular Disorders, Central Nervous System Diseases, Brain Infarction, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Transcranial Direct Current StimulationDevice
Also called Non-invasive brain stimulation, Brain stimulation, Enhancing stroke recovery
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
Sham Transcranial Direct Current StimulationDevice
Also called Non-invasive brain stimulation, Brain stimulation, Enhancing stroke recovery
A sham current runs between two electrode positions and might affect the underlying brain tissue.
| Study group | Role | What they receive |
|---|---|---|
| Real-tDCS + PT-OT | Active comparator | Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min. Receives: Device: Real Transcranial Direct Current Stimulation |
| Sham-tDCS + PT-OT | Sham comparator | Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region. Receives: Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Upper Extremity Motor Impairment
This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.
Measured: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
Secondary outcomes (1)
Wolf-Motor-Function-Test
The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed.
Measured: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startJun 2006
- Primary completion1 Feb 2013
- Study completion1 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gottfried Schlaug, Beth Israel Deaconess Medical Center
- Investigators
- Gottfried Schlaug, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center / Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792428
- Sponsor's protocol ID
- 2005P000346
- Other IDs
- R01NS045049
- Acronym
- TDCS+OT
- Status last verified
- May 2018
- First submitted
- 17 Nov 2008
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vines BW, Nair D, Schlaug G. Modulating activity in the motor cortex affects performance for the two hands differently depending upon which hemisphere is stimulated. Eur J Neurosci. 2008 Oct;28(8):1667-73. doi: 10.1111/j.1460-9568.2008.06459.x.
PubMed 18973584Vines BW, Cerruti C, Schlaug G. Dual-hemisphere tDCS facilitates greater improvements for healthy subjects' non-dominant hand compared to uni-hemisphere stimulation. BMC Neurosci. 2008 Oct 28;9:103. doi: 10.1186/1471-2202-9-103.
PubMed 18957075Nair DG, Hutchinson S, Fregni F, Alexander M, Pascual-Leone A, Schlaug G. Imaging correlates of motor recovery from cerebral infarction and their physiological significance in well-recovered patients. Neuroimage. 2007 Jan 1;34(1):253-63. doi: 10.1016/j.neuroimage.2006.09.010. Epub 2006 Oct 27.
PubMed 17070707Vines BW, Nair DG, Schlaug G. Contralateral and ipsilateral motor effects after transcranial direct current stimulation. Neuroreport. 2006 Apr 24;17(6):671-4. doi: 10.1097/00001756-200604240-00023.
PubMed 16603933Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
PubMed 21068427
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Motor Recovery After Stroke Using tDCS
- ClinicalTrials.gov ID
- NCT00792428
- Acronym / sponsor ID
- TDCS+OT / 2005P000346
- Conditions
- Stroke, Cerebrovascular Accident, CVA, Acute Stroke, Acute Cerebrovascular Accident, Apoplexy
- Keywords
- Stroke, Ischemia, Infarction, Cerebrovascular Disorder, Central Nervous System Diseases, Brain Infarction, Brain Ischemia, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2006
- Primary completion
- 1 Feb 2013 (actual)
- Study completion
- 1 Feb 2013 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Posted 11 Jul 2017
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 non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-tDCS + PT-OT | Active comparator | Device: Real Transcranial Direct Current StimulationEach subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min. |
| Sham-tDCS + PT-OT | Sham comparator | Device: Sham Transcranial Direct Current StimulationEach subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First time clinical ischemic stroke or cerebrovascular accident
- At least 5 months out from first ischemic stroke prior to study enrollment
Key exclusion criteria (6 listed)
- More than 1 stroke (older strokes)
- Significant pre-stroke disability
- A terminal medical illness or disorder with survival of less than 1 year
- Co-existent major neurological or psychiatric diseases (e.g., epilepsy)
- Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents
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 |
|---|---|---|
| Real Transcranial Direct Current StimulationAlso: Non-invasive brain stimulation, Brain stimulation, Enhancing stroke recoveryA direct current runs between two electrode positions and affects the excitability of the underlying brain tissue | Device | Real-tDCS + PT-OT |
| Sham Transcranial Direct Current StimulationAlso: Non-invasive brain stimulation, Brain stimulation, Enhancing stroke recoveryA sham current runs between two electrode positions and might affect the underlying brain tissue. | Device | Sham-tDCS + PT-OT |
Primary outcome
Fugl-Meyer Assessment of Upper Extremity Motor Impairment
Time frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.
1 secondary outcome
Wolf-Motor-Function-Test
Time frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18973584Vines BW, Nair D, Schlaug G. Modulating activity in the motor cortex affects performance for the two hands differently depending upon which hemisphere is stimulated. Eur J Neurosci. 2008 Oct;28(8):1667-73. doi: 10.1111/j.1460-9568.2008.06459.x.
- Background: PubMed 18957075Vines BW, Cerruti C, Schlaug G. Dual-hemisphere tDCS facilitates greater improvements for healthy subjects' non-dominant hand compared to uni-hemisphere stimulation. BMC Neurosci. 2008 Oct 28;9:103. doi: 10.1186/1471-2202-9-103.
- Background: PubMed 17070707Nair DG, Hutchinson S, Fregni F, Alexander M, Pascual-Leone A, Schlaug G. Imaging correlates of motor recovery from cerebral infarction and their physiological significance in well-recovered patients. Neuroimage. 2007 Jan 1;34(1):253-63. doi: 10.1016/j.neuroimage.2006.09.010. Epub 2006 Oct 27.
- Background: PubMed 16603933Vines BW, Nair DG, Schlaug G. Contralateral and ipsilateral motor effects after transcranial direct current stimulation. Neuroreport. 2006 Apr 24;17(6):671-4. doi: 10.1097/00001756-200604240-00023.
- Results publication: PubMed 21068427Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
- Individual participant dataSharing planned: No
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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.
Gottfried Schlaug, MD, PhD principal investigator
Beth Israel Deaconess Medical Center / Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Transcranial Direct Current Stimulation in people with Stroke and 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 2 inclusion and 6 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 4 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fugl-Meyer Assessment of Upper Extremity Motor Impairment (time frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days). 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 NCT00792428, which also lists 5 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 4 Jun 2018.