fMRI Neurofeedback for Motor Rehabilitation

NCT02089776 | Terminated

• 2 other identifiers: 14006914-N-0069
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; fMRI

Keywords

Stroke; fMRI; Real Time fMRI Feedback

Outcome Measures

Primary Outcomes (1)

• Change in neural functional connectivity as measured by fMRI.

  Immediately after intervention; up to 6 months post-intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age 18 to 80
• Have a normal neurological exam
• Have the capacity to give informed consent
• 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
• 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.
• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Albin RL, Mink JW. Recent advances in Tourette syndrome research. Trends Neurosci. 2006 Mar;29(3):175-82. doi: 10.1016/j.tins.2006.01.001. Epub 2006 Jan 23.

  PMID: 16430974 BACKGROUND

• 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. doi: 10.1016/s0165-0173(96)00011-2.

  PMID: 8957561 BACKGROUND

• 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. doi: 10.1097/00001756-200007140-00012.

  PMID: 10923655 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leonardo G Cohen, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 18, 2014
• Study Start: March 12, 2014
• Primary Completion: March 8, 2018
• Study Completion: March 8, 2018
• Last Updated: December 17, 2019

Record last verified: 2018-03-08

Locations

US (1)