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StrokeNCT02089776

fMRI Neurofeedback for Motor Rehabilitation

An observational study of Stroke and fMRI, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, fMRI
How many people
7 participants
Where
1 siteUnited States
Study dates
12 Mar 2014to 8 Mar 2018
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

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

Who cannot join

  • 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):
Show all 20Show fewer
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Real-time fMRI Neurofeedback for Motor Rehabilitation

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.
Read more

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.
Read the detailed description

Objective:

The objective of this study is to understand whether healthy volunteers and patients with chronic stroke resulting in hemiparesis can learn how to modulate their brain activity using feedback during real-time functional magnetic resonance imaging (rtfMRI), and whether such feedback training can lead to improvement in motor rehabilitation in chronic stroke patients.

Study population:

This study will be carried out in two parallel phases. In Phase 1, we will study learning to control brain functional activation (feedback technique using rtfMRI) in adult healthy volunteers; in Phase 2, we will study adult patients with chronic stroke. In both phases, we intend to study whether feedback training with rtfMRI leads to increased control of brain activity and whether this correlates with improvements in motor control in healthy participants and improvement in motor function, in chronic stroke patients, both immediately after training and at later time points. The reason for carrying out this study in parallel is that, as stated recently by Dr Petra Kaufman during a PIRC meeting, patients with brain lesions may benefit from this approach even if healthy volunteers do not.

Design:

Phase 1: We will test if healthy volunteers can learn to modulate their own brain connectivity using feedback of connectivity patterns between two brain regions during an rtfMRI neurofeedback paradigm.

Phase 2: We will test if chronic stroke patients can learn to modulate their brain activity and connectivity similar to the healthy volunteers, and if such learning can improve function.

Outcome measures:

The primary outcome for Phases 1 and 2 is the difference in brain activation and brain connectivity after feedback training compared to baseline. Secondary outcomes for both phases include: 1) changes in brain connectivity during rest, and when no feedback image is displayed (structural and/or functional connectivity), 2) changes in motor behavior after training compared to baseline, both immediately after and following a time delay, and 3) correlations between changes in behavior and changes in brain activity and brain connectivity (as measured in 1 and 2).

Conditions
Stroke, fMRI
Keywords
Stroke, fMRI, Real Time fMRI Feedback
Medical subject headings
Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in neural functional connectivity as measured by fMRI.

    Measured: Immediately after intervention; up to 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2014 (estimated)
  2. Study start12 Mar 2014
  3. Primary completion8 Mar 2018
  4. Study completion8 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02089776
Sponsor's protocol ID
140069
Other IDs
14-N-0069
Status last verified
8 Mar 2018
First submitted
12 Mar 2014
Last updated
17 Dec 2019
Results posted
No

Publications

  • 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.

    PubMed 16430974

  • 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.

    PubMed 8957561

  • 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.

    PubMed 10923655

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and fMRI, 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 3 inclusion and 20 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 17 Dec 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.

What does the primary outcome measure?

Change in neural functional connectivity as measured by fMRI. (time frame: Immediately after intervention; up to 6 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02089776, 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 17 Dec 2019.

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