Stroke Clinical Trial
Official title:
Real-time fMRI Neurofeedback for Motor Rehabilitation
Verified date | March 8, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- People can learn to use feedback about brain activity to change that activity. Researchers
want to see if people who have had a stroke can change their brain activity by practice and
thought with feedback, and if that improves motor control. They will study brain activity in
people who have and have not had strokes.
Objectives:
- To see if people with stroke can change their brain activity and improve motor control by
practice and thought.
Eligibility:
- Adults 18 80 years old who have had a stroke.
- Healthy volunteers 18 80 years old.
Design:
- Participants will be screened with a medical history, MRI, and physical exam. For MRI, a
magnetic field and radio waves take pictures of the brain. Participants lie on a table
that slides in and out of a cylinder. They will be in the scanner less than 2 hours,
lying still for up to 15 minutes at a time. The scanner makes loud noises. Participants
will get earplugs.
- Participants will have up to 3 scanning visits and up to 3 follow-up visits within 24
weeks. Visits may include screening, MRI, functional MRI (fMRI), questionnaires, and
simple motor tests. Stroke participants may take additional motor tests, including
transcranial magnetic stimulation (TMS).
- fMRI: During this MRI, small metal disks may be taped to the skin or a fabric glove with
small wires in it may be used to monitor hand movements. Heart rate and breathing may
also be monitored. Participants may be monitored by video and asked to perform tasks.
- TMS: A brief electrical current goes through a coil on the scalp. It creates a magnetic
pulse that stimulates the brain. Participants may be asked to perform simple actions.
Finger or hand movements may be recorded.
Status | Terminated |
Enrollment | 7 |
Est. completion date | March 8, 2018 |
Est. primary completion date | March 8, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
- INCLUSION/EXCLUSION CRITERIA: Inclusion criteria for healthy volunteers: - Age 18 to 80 - Have a normal neurological exam - Have the capacity to give informed consent Exclusion criteria for healthy volunteers:<TAB> - Pregnancy - Any report on the MRI safety questionnaire that prevents them from safely undergoing an MRI scan (e.g., metal implants) as per MRI center questionnaire - History of claustrophobia - Inability to carry out the task during scanning. - Any medical condition that would prevent them from lying flat for up to 2 hours Inclusion criteria for all patients with hemiparesis after stroke (regardless of doing TMS or not): - Aged 18 to 80 - Stroke onset greater than 3 months prior to participation in the study - Hemiparesis due to stroke involving the upper extremity - Have the capacity to give informed consent. If the investigator feels the volunteer s capacity to give informed consent is questionable, the NIH Human Subjects Protection Unit (HSPU) will be requested to determine the individual s ability to consent. Exclusion criteria for patients with hemiparesis after stroke:<TAB> - Pregnancy - Any report on the MRI safety questionnaire that prevents them from safely undergoing an MRI scan (e.g., metal implants) as per the MRI center questionnaire - History of claustrophobia - Inability to carry out the task during scanning. - Any medical condition that would prevent them from lying flat for up to 2 hours Given the heterogeneity of our population after stroke, we do not have a strong hypothesis about the effects of any specific medications on the experimental outcomes. Thus, medications are not listed as an exclusion criteria because they do not pose a concern. Furthermore, to take advantage of the heterogeneity of the lesion location on the experimental outcomes, we will perform a post-hoc stratification by lesion location in this initial study with stroke patients. There is little data to support a specific hypothesis that lesion size/location will contribute to differences in the participant s ability to successfully perform the task (e.g., control his/her neural activity using rtfMRI neurofeedback). The one prior study using rtfMRI with individuals with stroke recruited two participants with internal capsule lesions only. Thus, in this study we will stratify participants by lesion location in posthoc analyses and use this resulting information to inform future protocols for stroke patients using rtfMRI neurofeedback. Exclusion for TMS portion specifically: - Have metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye - Have epilepsy or history of seizures, or being on medication for epilepsy. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Albin RL, Mink JW. Recent advances in Tourette syndrome research. Trends Neurosci. 2006 Mar;29(3):175-82. Epub 2006 Jan 23. Review. — View Citation
Augustine JR. Circuitry and functional aspects of the insular lobe in primates including humans. Brain Res Brain Res Rev. 1996 Oct;22(3):229-44. Review. — View Citation
Banzett RB, Mulnier HE, Murphy K, Rosen SD, Wise RJ, Adams L. Breathlessness in humans activates insular cortex. Neuroreport. 2000 Jul 14;11(10):2117-20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in neural functional connectivity as measured by fMRI. | Immediately after intervention; up to 6 months post-intervention |
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