Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242242
Status:
TERMINATED
Last Update Posted:
2019-11-25
First Post:
2005-10-19
Brief Title:
Moving a Paralyzed Hand Through Use of a Brain-Computer Interface
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Moving a Paralyzed Hand Through a Brain-Computer Interface Controlled by the Affected Hemisphere After Stroke or Traumatic Brain Injury
Status:
TERMINATED
Status Verified Date:
2013-07-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 persons 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 subjects 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
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 subjects 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-N-0012 | None | None | None |