Cerebrovascular AccidentPhase 1NCT00050128
Preliminary Study of Transcranial Magnetic Stimulation for Stroke Rehabilitation
A Phase 1 study testing rTMS, Magstim in people with Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation (TMS), together with exercise, for rehabilitation of chronic stroke patients. It will identify the optimum stimulation settings (within the limits of current safety guidelines) to be used in a later rehabilitation study and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- rTMS, Magstim
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2002to 24 Oct 2007
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fifteen adult and impaired patients (right or left) with residual arm function who have had a single monohemispheric ischemic or hemorrhagic stroke (documented by CT or MRI) at least 6 months before, without severe proprioceptive deficits, independent of previous physical therapy will be included.
- They should be able to perform the pinch task.
- Their gender or ethnic origin will not provide bias for inclusion to the study.
- All subjects will sign an informed consent prior to participation in the trial.
Who cannot join
- Exclusion criteria for the trial will include any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke.
- Any individual who is on medication which is known to lower seizure threshold, or who has a pacemaker, an implanted medical pump, a metal plate, a metal plate or metal object in the skull or eye (for example after brain surgery) will be excluded.
- Additional exclusion include patients with:
- History of more than one stroke;
- Large cortical, cerebellar, or brainstem lesions;
- An inability to extend metacarpophalangeal (MP) joints at least 10-20 degrees;
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- Substantially recovered motor function;
- Severe depression;
- Poor motivational capacity, or severe language disturbances (particularly of receptive nature);
- Severe spasticity/pain;
- Bilateral motor problems;
- Serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less);
- Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
- Uncontrollable issues due to natural aging;
- History of seizure(s).
- All patients will underfo electroencephalogram (EEG) examination prior to rTMS experiment as a part of the screening procedure.
- Patients without any history of seizures, but with any sign of increased cerebral activity in the EEG will be excluded.
- Women who are pregnant may not participate and women who are of childbearing years must be post-menopausal, sterile, or practicing adequate birth control.
- Children will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Repetitive Transcranial Magnetic Stimulation in Chronic Stroke Patients. Dose Effect on Motor Cortex Excitability, Motor Performance, and Safety Using Different Stimulation Parameters
This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation (TMS), together with exercise, for rehabilitation of chronic stroke patients. It will identify the optimum stimulation settings (within the limits of current safety guidelines) to be used in a later rehabilitation study and confirm the safety of the procedure at these settings. Some previous studies using TMS to treat movement disorders such as Parkinson's disease have shown improvement in motor function; others have not. The results of this study may provide information to help researchers design better rehabilitation treatments after stroke.
Stroke patients with residual arm function and no history of seizures may be eligible for this study. The stroke must have occurred at least 6 months before entry into the study and must have affected only one side of the brain.
For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the outer part of the brain, called the cortex. This may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may affect movements or reflexes. Subjects are asked to make movements, do simple tasks, or tense muscles. Metal electrodes are taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation. The testing lasts 2-3 hours.
Read the detailed description
Stroke survivors are often left with permanent physical and mental disabilities that create a major social and economic burden. Many of these patients receive different therapies in an attempt to improve their independence and quality of life. However, most of the current strategies are focused on the acute stage after stroke and are of limited influence in improving stroke outcome. One of the main problems of patients who have suffered a stroke is the difficulty in appropriately using the hand contralateral to the lesioned hemisphere; to date we have no successful means to improve the hand function in chronic stages of stroke. This protocol attempts to address this problem.
A promising technique is repetitive transcranial magnetic stimulation (rTMS) that, so far, has produced some effects on motor function on other movement disorders like Parkinson's disease (PD). We hypothesize that rTMS will have a beneficial effect on motor function in chronic stroke patients. Specifically, we propose to look at the effect of 20 and 25 Hz stimulation since these types of stimulation have been shown to increase the excitability of the cerebral cortex.
The purpose of this protocol is to investigate the effect of repetitive transcranial stimulation (rTMS) on the motor cortex of chronic stroke patients and motor function. Four different stimulation parameters within the limits of current safety guidelines will be used. We plan to determine; 1) which rTMS stimulation parameters induce more cortex excitability, 2) whether there is any improvement of hand motor function after rTMS, and 3) if the applied stimulation parameters are safe in chronic stroke patients. The optimal parameters will be subsequently proposed for use in an experimental protocol for rehabilitation.
- Conditions
- Cerebrovascular Accident
- Being tested
- rTMS, Magstim
- Keywords
- Rehabilitation, Plasticity, Frequency, Inhibition, Pinch, Stroke
- Medical subject headings
- Stroke, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS, MagstimDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2002 (estimated)
- Study start18 Nov 2002
- Study completion24 Oct 2007
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 National Institute of Neurological Disorders and Stroke (NINDS)The 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 1
- Primary purpose
- Treatment
- Enrolment
- 15 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050128
- Sponsor's protocol ID
- 030049
- Other IDs
- 03-N-0049
- Status last verified
- 24 Oct 2007
- First submitted
- 21 Nov 2002
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
The uses of epidemiology in the study of the elderly. Report of a WHO Scientific Group on the Epidemiology of Aging. World Health Organ Tech Rep Ser. 1984;706:1-84. No abstract available.
PubMed 6437089
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation in Chronic Stroke Patients. Dose Effect on Motor Cortex Excitability, Motor Performance, and Safety Using Different Stimulation Parameters
- ClinicalTrials.gov ID
- NCT00050128
- Acronym / sponsor ID
- 030049
- Conditions
- Cerebrovascular Accident
- Keywords
- Rehabilitation, Plasticity, Frequency, Inhibition, Pinch, Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 18 Nov 2002
- Study completion
- 24 Oct 2007
- First posted
- 22 Nov 2002 (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.
This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation (TMS), together with exercise, for rehabilitation of chronic stroke patients. It will identify the optimum stimulation settings (within the limits of current safety guidelines) to be used in a later rehabilitation study and confirm the safety of the procedure at these settings. Some previous studies using TMS to treat movement disorders such as Parkinson's disease have shown improvement in motor function; others have not. The results of this study may provide information to help researchers design better rehabilitation treatments after stroke.
Stroke patients with residual arm function and no history of seizures may be eligible for this study. The stroke must have occurred at least 6 months before entry into the study and must have affected only one side of the brain.
For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the outer part of the brain, called the cortex. This may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may affect movements or reflexes. Subjects are asked to make movements, do simple tasks, or tense muscles. Metal electrodes are taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation. The testing lasts 2-3 hours.
Detailed description
Stroke survivors are often left with permanent physical and mental disabilities that create a major social and economic burden. Many of these patients receive different therapies in an attempt to improve their independence and quality of life. However, most of the current strategies are focused on the acute stage after stroke and are of limited influence in improving stroke outcome. One of the main problems of patients who have suffered a stroke is the difficulty in appropriately using the hand contralateral to the lesioned hemisphere; to date we have no successful means to improve the hand function in chronic stages of stroke. This protocol attempts to address this problem.
A promising technique is repetitive transcranial magnetic stimulation (rTMS) that, so far, has produced some effects on motor function on other movement disorders like Parkinson's disease (PD). We hypothesize that rTMS will have a beneficial effect on motor function in chronic stroke patients. Specifically, we propose to look at the effect of 20 and 25 Hz stimulation since these types of stimulation have been shown to increase the excitability of the cerebral cortex.
The purpose of this protocol is to investigate the effect of repetitive transcranial stimulation (rTMS) on the motor cortex of chronic stroke patients and motor function. Four different stimulation parameters within the limits of current safety guidelines will be used. We plan to determine; 1) which rTMS stimulation parameters induce more cortex excitability, 2) whether there is any improvement of hand motor function after rTMS, and 3) if the applied stimulation parameters are safe in chronic stroke patients. The optimal parameters will be subsequently proposed for use in an experimental protocol for rehabilitation.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Fifteen adult and impaired patients (right or left) with residual arm function who have had a single monohemispheric ischemic or hemorrhagic stroke (documented by CT or MRI) at least 6 months before, without severe proprioceptive deficits, independent of previous physical therapy will be included.
- They should be able to perform the pinch task.
- Their gender or ethnic origin will not provide bias for inclusion to the study.
- All subjects will sign an informed consent prior to participation in the trial.
Key exclusion criteria (19 listed)
- Exclusion criteria for the trial will include any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke.
- Any individual who is on medication which is known to lower seizure threshold, or who has a pacemaker, an implanted medical pump, a metal plate, a metal plate or metal object in the skull or eye (for example after brain surgery) will be excluded.
- History of more than one stroke;
- Large cortical, cerebellar, or brainstem lesions;
- An inability to extend metacarpophalangeal (MP) joints at least 10-20 degrees;
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 |
|---|---|---|
| rTMS, Magstim | Device | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 6437089The uses of epidemiology in the study of the elderly. Report of a WHO Scientific Group on the Epidemiology of Aging. World Health Organ Tech Rep Ser. 1984;706:1-84. No abstract available.
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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 study testing rTMS, Magstim in people with Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 19 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 2 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00050128, 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 2 Jul 2017.