StrokeNCT00242242
Moving a Paralyzed Hand Through Use of a Brain-Computer Interface
An observational study of Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will gain information on methods of control of a prosthetic arm in stroke patients or traumatic brain inury patients through a technique called "brain-computer interface" (BCI). BCI allows for direct communication between man and machine. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2005to 23 Jul 2013
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 80 years. Substantial unilateral motor impairment, defined by MRC scores less than or equal to 2.
- At least 12 months post thromboembolic non-hemorrhagic hemispheric or hemorrhagic hemispheric subcortical lesions.
- At least 12 months post mild to moderate traumatic brain injury.
- Between the ages of 18 and 80 years
Who cannot join
- We will exclude any stroke patient, TBI patient, or healthy volunteer if one of the following applies:
- History of alcohol or drug abuse.
- History of epilepsy (TMS and tDCS components only).
- Pregnancy
- MRI contraindications.
- Cardiac pacemakers.
Show all 33Show fewer
- Intracardiac lines.
- Implanted medication pumps.
- Neural stimulators.
- Eye, blood vessel, cochlear, or eye implants.
- Increased intracranial pressure as evaluated.
- Metal in the cranium except in the mouth.
- Dental braces.
- Metal fragments from occupational exposure.
- Surgical clips in or near the brain.
- Inability to perform study tasks.
- Serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less) that would prevent their ability to give informed consent and/or perform the study tasks.
- Uncontrolled medical (e.g. cardiovascular disease expressed as uncontrolled arrhythmias, shortness of breath, or overt signs of severe peripheral edema at the initial neurological exam, severe rheumatoid arthritis, arthritic joint deformity, active cancer or renal disease), or psychiatric problems as defined in the DSM IV.
- Post-traumatic seizures (TMS component only).
- Instability of psychoactive medication in the past 2 months.
- Pending litigation regarding the trauma.
- Absent changes in both Glascow Coma Scale and mental status following injury.
- Outpatients who are unable to make a 12-week commitment.
- Inpatients who are unable to make a 15 day commitment.
- Comprehensive aphasia.
- Cerebellar lesions.
- More than one stroke in the middle cerebral artery territory.
- Bilateral motor impairment.
- Initiation of an exercise or rehabilitation program that could affect experimental results.
- Outpatients who are unable to make a 12-week commitment.
- Inpatients who are unable to make a 15 day commitment.
- Comprehensive aphasia.
- Inability to make a 12-week commitment.
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: Moving a Paralyzed Hand Through a Brain-Computer Interface Controlled by the Affected Hemisphere After Stroke or Traumatic Brain Injury
This study will gain information on methods of control of a prosthetic arm in stroke patients or traumatic brain inury patients through a technique called "brain-computer interface" (BCI). BCI allows for direct communication between man and machine. Brain cells communicate by producing electrical impulses that help to create such things as thoughts, memory, consciousness and emotions. In BCI, brain waves are recorded by an electroencephalogram (EEG) through electrodes (small wires) attached to the scalp. The electrodes measure the electrical signals of the brain. These signals are sent to the computer, which translates them into device control commands as messages that reflect a person's intention. This type of brain activity comes from the sensorimotor areas of the brain and can be controlled through voluntarily training to control the hand prosthesis through the BCI.
Healthy normal volunteers and people who have had a stroke or traumatic brain injury more than 12 months ago and have paralysis in the right or left arm, hand or leg and who are between 18 and 80 years of age may be eligible for this study. Candidates are screened with a clinical and neurological examination and magnetic resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. During the procedure, the subject lies in the scanner for about 45 minutes, wearing ear plugs to muffle loud knocking sounds that occur with the scanning.
Read more
Participants undergo the following procedures:
- Sessions 1-2: Participants are connected to an EEG machine and familiarized with the hand orthosis (training device used in the study) and the tasks required for the study.
- Sessions 3-4: Participants receive baseline transcranial magnetic stimulation (TMS) and fMRI. For TMS, a wire coil is held on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject may feel a pulling sensation on the skin under the coil and there may be twitching in muscles of the face, arm or leg. The subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms. fMRI is like a standard MRI (see above), except it is done while the patient performs tasks to learn about brain activity involved in those tasks.
- Sessions 5-8: Participants are asked to repetitively move their hand (patients' paralyzed hand; healthy volunteers' normal hand), tongue and leg in response to three sound tones. After ten trials, they are asked to imagine the same movements 50 to 100 times while the EEG machine is recording brain activity.
- Sessions 9-14: Participants are trained in controlling the hand orthosis. The subject's hand is attached to the orthosis and asked to imagine that they are performing finger or hand movements. This continues until there is an 80-90 percent success rate in achieving hand movement.
- Sessions 15-16: Participants repeat TMS and fMRI for comparison before and after training with the hand orthosis.
- Sessions 17-28: Participants receive additional training with the hand orthosis device (as in sessions 5-8), focusing only on the hand and not other parts of the body.
- Sessions 29-30: Participants undergo repeat TMS and fMRI to compare with the effect following additional training with the hand orthosis.
- Sessions 31-32: Optional makeup sessions if needed because of scheduling problems.
Participants are evaluated in the clinic after 3 months to see if they have benefited from the study.
Read the detailed description
Objective: Individuals who have suffered a stroke or traumatic brain injury (TBI) may benefit from the development of new rehabilitative interventions that can improve motor recovery after injury. The purpose of this protocol is to test the hypothesis that oscillatory brain activity that originates in the affected hemisphere in the form of desynchronization of Mu-rhythm of patients with chronic stroke or TBI can be used to drive movements of an orthosis attached to a paralyzed hand through a Brain Computer Interface (BCI). Mu-rhythm is a type of brain wave activity that originates in the sensorimotor areas of the brain that can be controlled voluntarily; it is present in the affected hemisphere of stroke patients and can be used to control the hand prostheses through the BCI interface. Control of Mu-rhythm amplitudes by volition requires training since it does not happen spontaneously. A proof-of-principle sub-experiment will test the hypothesis that in stroke survivors non-invasive cortical stimulation of the ipsilesional primary motor cortex (M1) will facilitate learning to control a hand orthosis through a BCI device. This is the purpose of the training: to teach the subject to control Mu-rhythms.
Study population: The study population will consist of individuals with chronic stroke or TBI that have virtually no movement of their paretic hand and age- and gender- matched healthy volunteers. Healthy volunteers, which may include the age- and gender- matched volunteers, will be recruited to refine instructions given to patients.
Design: This is primarily an intraindividual comparison study, designed to determine if this brain-computer interface (BCI) approach contributes to drive grasping motions through a BCI interface and hand-orthosis. To test the effect of non-invasive cortical stimulation 21 stroke patients will be randomly assigned to three groups (group A, anodal stimulation; group B, cathodal stimulation; group C, sham stimulation). Study of normal volunteers will contribute to (a) set up of the experiment, (b) identifying differences in the training time required to modulate Mu-rhythm in healthy volunteers and patients and (c) to isolate training effects as measured by TMS and fMRI on the healthy brain from training effects on brains affected with stroke or TBI. This information will be treated descriptively within the framework of this protocol but it is also important for designing future studies.
Outcome measures: Behavioral endpoint measure: ability to drive the paralyzed hand orthosis in flexion and extension motions using Mu-rhythm. Physiological endpoint measures: peak fMRI activity in the hand knob representation, and corticomotor excitability as tested with TMS and MEG in ipsilesional and contralesional hand knob representations. Normal volunteers will undergo evaluation of the same physiological endpoint measures as patients.
- Conditions
- Stroke
- Keywords
- Stroke, BCI, Healthy Volunteer, HV
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study start17 Oct 2005
- Study completion23 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Observational
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM)
- Investigators
- Leonardo G Cohen, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242242
- Sponsor's protocol ID
- 060012
- Other IDs
- 06-N-0012
- Status last verified
- 23 Jul 2013
- First submitted
- 19 Oct 2005
- Last updated
- 25 Nov 2019
- Results posted
- No
Publications
Ward NS, Cohen LG. Mechanisms underlying recovery of motor function after stroke. Arch Neurol. 2004 Dec;61(12):1844-8. doi: 10.1001/archneur.61.12.1844.
PubMed 15596603Dobkin BH. Driving cognitive and motor gains with rehabilitation after brain and spinal cord injury. Curr Opin Neurol. 1998 Dec;11(6):639-41. doi: 10.1097/00019052-199812000-00005. No abstract available.
PubMed 9870130Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
PubMed 11994754
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moving a Paralyzed Hand Through a Brain-Computer Interface Controlled by the Affected Hemisphere After Stroke or Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00242242
- Acronym / sponsor ID
- 060012
- Conditions
- Stroke
- Keywords
- Stroke, BCI, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM)
- Study start
- 17 Oct 2005
- Study completion
- 23 Jul 2013
- First posted
- 19 Oct 2005 (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 study will gain information on methods of control of a prosthetic arm in stroke patients or traumatic brain inury patients through a technique called "brain-computer interface" (BCI). BCI allows for direct communication between man and machine. Brain cells communicate by producing electrical impulses that help to create such things as thoughts, memory, consciousness and emotions. In BCI, brain waves are recorded by an electroencephalogram (EEG) through electrodes (small wires) attached to the scalp. The electrodes measure the electrical signals of the brain. These signals are sent to the computer, which translates them into device control commands as messages that reflect a person's intention. This type of brain activity comes from the sensorimotor areas of the brain and can be controlled through voluntarily training to control the hand prosthesis through the BCI.
Healthy normal volunteers and people who have had a stroke or traumatic brain injury more than 12 months ago and have paralysis in the right or left arm, hand or leg and who are between 18 and 80 years of age may be eligible for this study. Candidates are screened with a clinical and neurological examination and magnetic resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. During the procedure, the subject lies in the scanner for about 45 minutes, wearing ear plugs to muffle loud knocking sounds that occur with the scanning.
Participants undergo the following procedures:
- Sessions 1-2: Participants are connected to an EEG machine and familiarized with the hand orthosis (training device used in the study) and the tasks required for the study.
- Sessions 3-4: Participants receive baseline transcranial magnetic stimulation (TMS) and fMRI. For TMS, a wire coil is held on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject may feel a pulling sensation on the skin under the coil and there may be twitching in muscles of the face, arm or leg. The subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms. fMRI is like a standard MRI (see above), except it is done while the patient performs tasks to learn about brain activity involved in those tasks.
- Sessions 5-8: Participants are asked to repetitively move their hand (patients' paralyzed hand; healthy volunteers' normal hand), tongue and leg in response to three sound tones. After ten trials, they are asked to imagine the same movements 50 to 100 times while the EEG machine is recording brain activity.
- Sessions 9-14: Participants are trained in controlling the hand orthosis. The subject's hand is attached to the orthosis and asked to imagine that they are performing finger or hand movements. This continues until there is an 80-90 percent success rate in achieving hand movement.
- Sessions 15-16: Participants repeat TMS and fMRI for comparison before and after training with the hand orthosis.
- Sessions 17-28: Participants receive additional training with the hand orthosis device (as in sessions 5-8), focusing only on the hand and not other parts of the body.
- Sessions 29-30: Participants undergo repeat TMS and fMRI to compare with the effect following additional training with the hand orthosis.
- Sessions 31-32: Optional makeup sessions if needed because of scheduling problems.
Participants are evaluated in the clinic after 3 months to see if they have benefited from the study.
Detailed description
Objective: Individuals who have suffered a stroke or traumatic brain injury (TBI) may benefit from the development of new rehabilitative interventions that can improve motor recovery after injury. The purpose of this protocol is to test the hypothesis that oscillatory brain activity that originates in the affected hemisphere in the form of desynchronization of Mu-rhythm of patients with chronic stroke or TBI can be used to drive movements of an orthosis attached to a paralyzed hand through a Brain Computer Interface (BCI). Mu-rhythm is a type of brain wave activity that originates in the sensorimotor areas of the brain that can be controlled voluntarily; it is present in the affected hemisphere of stroke patients and can be used to control the hand prostheses through the BCI interface. Control of Mu-rhythm amplitudes by volition requires training since it does not happen spontaneously. A proof-of-principle sub-experiment will test the hypothesis that in stroke survivors non-invasive cortical stimulation of the ipsilesional primary motor cortex (M1) will facilitate learning to control a hand orthosis through a BCI device. This is the purpose of the training: to teach the subject to control Mu-rhythms.
Study population: The study population will consist of individuals with chronic stroke or TBI that have virtually no movement of their paretic hand and age- and gender- matched healthy volunteers. Healthy volunteers, which may include the age- and gender- matched volunteers, will be recruited to refine instructions given to patients.
Design: This is primarily an intraindividual comparison study, designed to determine if this brain-computer interface (BCI) approach contributes to drive grasping motions through a BCI interface and hand-orthosis. To test the effect of non-invasive cortical stimulation 21 stroke patients will be randomly assigned to three groups (group A, anodal stimulation; group B, cathodal stimulation; group C, sham stimulation). Study of normal volunteers will contribute to (a) set up of the experiment, (b) identifying differences in the training time required to modulate Mu-rhythm in healthy volunteers and patients and (c) to isolate training effects as measured by TMS and fMRI on the healthy brain from training effects on brains affected with stroke or TBI. This information will be treated descriptively within the framework of this protocol but it is also important for designing future studies.
Outcome measures: Behavioral endpoint measure: ability to drive the paralyzed hand orthosis in flexion and extension motions using Mu-rhythm. Physiological endpoint measures: peak fMRI activity in the hand knob representation, and corticomotor excitability as tested with TMS and MEG in ipsilesional and contralesional hand knob representations. Normal volunteers will undergo evaluation of the same physiological endpoint measures as patients.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18 and 80 years. Substantial unilateral motor impairment, defined by MRC scores less than or equal to 2.
- At least 12 months post thromboembolic non-hemorrhagic hemispheric or hemorrhagic hemispheric subcortical lesions.
- At least 12 months post mild to moderate traumatic brain injury.
- Between the ages of 18 and 80 years
Key exclusion criteria (33 listed)
- We will exclude any stroke patient, TBI patient, or healthy volunteer if one of the following applies:
- History of alcohol or drug abuse.
- History of epilepsy (TMS and tDCS components only).
- Pregnancy
- MRI contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Background: PubMed 15596603Ward NS, Cohen LG. Mechanisms underlying recovery of motor function after stroke. Arch Neurol. 2004 Dec;61(12):1844-8. doi: 10.1001/archneur.61.12.1844.
- Background: PubMed 9870130Dobkin BH. Driving cognitive and motor gains with rehabilitation after brain and spinal cord injury. Curr Opin Neurol. 1998 Dec;11(6):639-41. doi: 10.1097/00019052-199812000-00005. No abstract available.
- Background: PubMed 11994754Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
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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.
Leonardo G Cohen, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, 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 33 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 25 Nov 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 was stopped early. Results are not available in the source record.
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 NCT00242242, which also lists 3 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 25 Nov 2019.