fMRI Neurofeedback for Motor Rehabilitation
| Status: | Terminated |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/31/2019 |
| Start Date: | March 12, 2014 |
| End Date: | March 8, 2018 |
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.
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.
- 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.
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).
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).
- 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:
- 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:
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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