Stroke Clinical Trial
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.
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).
;
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