Brain InfarctionNCT01201629
Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm
A study testing t DC stimulation and tDCStimulation in people with Brain Infarction and Brain Ischemia, run by University of Oklahoma at 1 site in United States.
Trial summary
Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Brain Infarction, Brain Ischemia
- What is being tested?
- t DC stimulation and tDCStimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2010to Dec 2015
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
- Ischemic stroke documented clinically and by neuroimaging.
- Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
- Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
- Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.
Who cannot join
- Hemorrhagic strokes
- Patient's with an episode post-stroke seizure or history of epilepsy.
- Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).
- On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,
- Stroke patients with implanted pacemakers and defibrillators.
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Does Transcranial Direct Current Stimulation Improve Functional Motor Recovery in the Affected Arm-Hand in Patients After an Acute Ischemic Stroke: A Randomized Control Trial
Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.
Read the detailed description
Study design:
Patients Successive admissions to the stroke service of the Veterans Affairs Medical Center with ischemic strokes will participate in this study.
Eligibility criteria:
Inclusion criteria:
- Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
- Ischemic stroke documented clinically and by neuroimaging.
- Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
- Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
- Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.
Exclusion criteria:
- Hemorrhagic strokes
- Patient's with an episode post-stroke seizure or history of epilepsy.
- Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).
- On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,
- Stroke patients with implanted pacemakers and defibrillators.
- Refusal to provide informed consent
- Conditions
- Brain Infarction, Brain Ischemia
- Being tested
- t DC stimulation, tDCStimulation
- Keywords
- Ischemic Strokes, t DC stimulation, Functional recovery
- Medical subject headings
- Brain Infarction, Brain Ischemia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
t DC stimulationDevice
Also called Sham transcranial DC brain stimulator
tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.
tDCStimulationDevice
Also called Experimental tDC stimulator
1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.
| Study group | Role | What they receive |
|---|---|---|
| t DC stimulation | Sham comparator | Sham transcranial direct current stimulation tDCS induces slight short-lasting tingling with onset of the stimulation. These sensations usually fade away in seconds. Sham interventions are essential to blind the subject and the assessor in order to obtain unbiased assessment of intervention effects Receives: Device: t DC stimulation; Device: tDCStimulation |
| tDC stimulation | Experimental | Actual DC stimulation Receives: Device: t DC stimulation; Device: tDCStimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Functional Independence Measure (TFIM) Change Scores
The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.
Measured: from baseline to 4-weeks of therapy
Secondary outcomes (2)
Action Research Arm Test (ARAT) Change Scores
The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal
Measured: baseline to after 4-weeks of therapy
Discharge Disposition
Patient discharged home or to sub-acute facility
Measured: after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study start16 Sep 2010
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Slow accrual over 6 year period
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.
- Other trials for Brain InfarctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- Meheroz H Rabadi, MD, MRCPI, Principal investigator, Oklahoma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201629
- Sponsor's protocol ID
- 1620
- Status last verified
- Mar 2017
- First submitted
- 7 Sep 2010
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Transcranial Direct Current Stimulation Improve Functional Motor Recovery in the Affected Arm-Hand in Patients After an Acute Ischemic Stroke: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01201629
- Acronym / sponsor ID
- 1620
- Conditions
- Brain Infarction, Brain Ischemia
- Keywords
- Ischemic Strokes, t DC stimulation, Functional recovery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual over 6 year period
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- 16 Sep 2010 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Posted 10 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.
Detailed description
Study design:
Patients Successive admissions to the stroke service of the Veterans Affairs Medical Center with ischemic strokes will participate in this study.
Eligibility criteria:
Inclusion criteria:
- Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
- Ischemic stroke documented clinically and by neuroimaging.
- Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
- Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
- Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.
Exclusion criteria:
- Hemorrhagic strokes
- Patient's with an episode post-stroke seizure or history of epilepsy.
- Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).
- On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,
- Stroke patients with implanted pacemakers and defibrillators.
- Refusal to provide informed consent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| t DC stimulation | Sham comparator | Device: t DC stimulation, Device: tDCStimulationSham transcranial direct current stimulation tDCS induces slight short-lasting tingling with onset of the stimulation. These sensations usually fade away in seconds. Sham interventions are essential to blind the subject and the assessor in order to obtain unbiased assessment of intervention effects |
| tDC stimulation | Experimental | Device: t DC stimulation, Device: tDCStimulationActual DC stimulation |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
- Ischemic stroke documented clinically and by neuroimaging.
- Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
Key exclusion criteria (6 listed)
- Hemorrhagic strokes
- Patient's with an episode post-stroke seizure or history of epilepsy.
- Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).
- On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,
- Stroke patients with implanted pacemakers and defibrillators.
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 |
|---|---|---|
| t DC stimulationAlso: Sham transcranial DC brain stimulatortDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability. | Device | t DC stimulation, tDC stimulation |
| tDCStimulationAlso: Experimental tDC stimulator1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only. | Device | t DC stimulation, tDC stimulation |
Primary outcome
Total Functional Independence Measure (TFIM) Change Scores
Time frame: from baseline to 4-weeks of therapy
The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.
2 secondary outcomes
Action Research Arm Test (ARAT) Change Scores
Time frame: baseline to after 4-weeks of therapy
Discharge Disposition
Time frame: after 4 weeks of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Meheroz H Rabadi, MD, MRCPI principal investigator
Oklahoma University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing t DC stimulation and tDCStimulation in people with Brain Infarction and Brain Ischemia, run by University of Oklahoma 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 7 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: stopped early, as of the sponsor's last update on 10 May 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?
Yes. Results are posted in the registry (first posted 10 May 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?
Total Functional Independence Measure (TFIM) Change Scores (time frame: from baseline to 4-weeks of therapy). 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 10 May 2017.