StrokeNCT03067818
Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
A study testing Unaffected Transcranial Magnetic Stimulation and Affected Transcranial Magnetic Stimulation in people with Stroke and Hemiparesis, run by George Mason University at 1 site in United States.
Trial summary
This study examines the effect of non-invasive brain stimulation targeting different brain areas on movement of the affected arm post-stroke. Participants will receive stimulation to each of 3 different brain areas combined with a session of arm exercise. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Hemiparesis, Cerebral Vascular Accident
- What is being tested?
- Unaffected Transcranial Magnetic Stimulation and Affected Transcranial Magnetic Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2017to 28 Aug 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 6 months post-stroke
- Loss of voluntary finger movement in the affected hand
- Some voluntary movement of affected shoulder and/or elbow
Who cannot join
- Brainstem or cerebellar stroke
- Severe cognitive or language deficits
- Epilepsy or other seizure disorder
- Central nervous system disease or disorder other than stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
About this study
This study examines the effect of non-invasive brain stimulation targeting different brain areas on movement of the affected arm post-stroke. Participants will receive stimulation to each of 3 different brain areas combined with a session of arm exercise.
Read the detailed description
Small improvements in affected arm movement can be made with intensive physical practice. These improvements could potentially be enhanced by combining non-invasive brain stimulation with practice.
To develop such an intervention, it is necessary to understand which brain areas should be stimulated in which types of patients. It is probably more beneficial to target one side of the brain vs. the other, for example, depending on the characteristics of the stroke.
This study will examine the effect of stimulating one side of the brain vs. the other on the amount of improvement that occurs from physically practicing functional arm movements.
- Conditions
- Stroke, Hemiparesis, Cerebral Vascular Accident, Stroke, Ischemic
- Being tested
- Unaffected Transcranial Magnetic Stimulation, Affected Transcranial Magnetic Stimulation, Control Transcranial Magnetic Stimulation
- Keywords
- arm, rehabilitation, non-invasive brain stimulation, transcranial magnetic stimulation, upper extremity
- Medical subject headings
- Stroke, Paresis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unaffected Transcranial Magnetic StimulationProcedure or surgery
Non-invasive brain stimulation to unaffected hemisphere site prior to practice
Affected Transcranial Magnetic StimulationProcedure or surgery
Non-invasive brain stimulation to affected hemisphere site prior to practice
Control Transcranial Magnetic StimulationProcedure or surgery
Non-invasive brain stimulation to control site prior to practice
| Study group | Role | What they receive |
|---|---|---|
| Unaffected Hemisphere | Experimental | Application of "Unaffected Transcranial Magnetic Stimulation" to unaffected hemisphere site prior to physical practice Receives: Procedure: Unaffected Transcranial Magnetic Stimulation |
| Affected Hemisphere | Experimental | Application of "Affected Transcranial Magnetic Stimulation" to affected hemisphere site prior to physical practice Receives: Procedure: Affected Transcranial Magnetic Stimulation |
| Control Site | Active comparator | Application of "Control Transcranial Magnetic Stimulation" to control site prior to practice Receives: Procedure: Control Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in movement time
Percentage change in time it takes to move the arm a standardized distance
Measured: Baseline and 1 Day
Secondary outcomes (2)
Change in maximum reaching distance
Percentage change in maximum distance participant is able to reach
Measured: Baseline and 1 Day
Change in hand path kinematics
Percentage change in temporal and spatial movement of the hand during reaching
Measured: Baseline and 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start20 Jun 2017
- Primary completion15 Aug 2019
- Study completion28 Aug 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will receive stimulation targeting each brain area. The order in which the stimulation sites are targeted for each participant is randomized and there is a washout period of several weeks between each treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- MedStar National Rehabilitation Network
- Responsible party
- Sponsor
- Investigators
- Michelle Harris-Love, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067818
- Sponsor's protocol ID
- 1R21HD090516-01
- Status last verified
- Sep 2019
- First submitted
- 24 Feb 2017
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
- ClinicalTrials.gov ID
- NCT03067818
- Acronym / sponsor ID
- 1R21HD090516-01
- Conditions
- Stroke, Hemiparesis, Cerebral Vascular Accident, Stroke, Ischemic
- Keywords
- arm, rehabilitation, non-invasive brain stimulation, transcranial magnetic stimulation, upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- MedStar National Rehabilitation Network
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 1 Mar 2017 (actual)
- 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.
This study examines the effect of non-invasive brain stimulation targeting different brain areas on movement of the affected arm post-stroke. Participants will receive stimulation to each of 3 different brain areas combined with a session of arm exercise.
Detailed description
Small improvements in affected arm movement can be made with intensive physical practice. These improvements could potentially be enhanced by combining non-invasive brain stimulation with practice.
To develop such an intervention, it is necessary to understand which brain areas should be stimulated in which types of patients. It is probably more beneficial to target one side of the brain vs. the other, for example, depending on the characteristics of the stroke.
This study will examine the effect of stimulating one side of the brain vs. the other on the amount of improvement that occurs from physically practicing functional arm movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Each participant will receive stimulation targeting each brain area. The order in which the stimulation sites are targeted for each participant is randomized and there is a washout period of several weeks between each treatment.
| Arm | Type | Receives |
|---|---|---|
| Unaffected Hemisphere | Experimental | Procedure: Unaffected Transcranial Magnetic StimulationApplication of "Unaffected Transcranial Magnetic Stimulation" to unaffected hemisphere site prior to physical practice |
| Affected Hemisphere | Experimental | Procedure: Affected Transcranial Magnetic StimulationApplication of "Affected Transcranial Magnetic Stimulation" to affected hemisphere site prior to physical practice |
| Control Site | Active comparator | Procedure: Control Transcranial Magnetic StimulationApplication of "Control Transcranial Magnetic Stimulation" to control site prior to practice |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- More than 6 months post-stroke
- Loss of voluntary finger movement in the affected hand
- Some voluntary movement of affected shoulder and/or elbow
Key exclusion criteria (4 listed)
- Brainstem or cerebellar stroke
- Severe cognitive or language deficits
- Epilepsy or other seizure disorder
- Central nervous system disease or disorder other than stroke
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 |
|---|---|---|
| Unaffected Transcranial Magnetic StimulationNon-invasive brain stimulation to unaffected hemisphere site prior to practice | Procedure or surgery | Unaffected Hemisphere |
| Affected Transcranial Magnetic StimulationNon-invasive brain stimulation to affected hemisphere site prior to practice | Procedure or surgery | Affected Hemisphere |
| Control Transcranial Magnetic StimulationNon-invasive brain stimulation to control site prior to practice | Procedure or surgery | Control Site |
Primary outcome
Change in movement time
Time frame: Baseline and 1 Day
Percentage change in time it takes to move the arm a standardized distance
2 secondary outcomes
Change in maximum reaching distance
Time frame: Baseline and 1 Day
Change in hand path kinematics
Time frame: Baseline and 1 Day
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 11 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Michelle Harris-Love, PhD principal investigator
George Mason 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 Unaffected Transcranial Magnetic Stimulation and Affected Transcranial Magnetic Stimulation in people with Stroke and Hemiparesis, run by George Mason University 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 3 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: finished, as of the sponsor's last update on 11 Sep 2019. 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. 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?
Change in movement time (time frame: Baseline and 1 Day). 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 11 Sep 2019.