Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/5/2019 |
| Start Date: | April 17, 2009 |
| Contact: | Elaine P Considine, R.N. |
| Email: | considinee@ninds.nih.gov |
| Phone: | (301) 435-8518 |
Background:
- Many people can learn to use feedback about brain activity to modify that activity, but
is it not known if people with Tourette syndrome can modify their brain activity.
- Researchers have evidence that certain areas of the brain are involved in causing tics
in people with Tourette syndrome. If people with Tourette syndrome can use feedback
about brain activity to modify activity in those parts of the brain, they may be able to
modify their brain activity to help control the tics.
Objectives:
- To determine if people with and without Tourette syndrome can learn to use thought to
control brain activity.
- To test whether people who have Tourette syndrome can learn to control brain activities,
possibly helping to control tics.
Eligibility:
- Healthy volunteers ages 18 and older who are right-handed and are willing to not consume
caffeine or alcohol for 24 hours before the study visit.
- Patients with Tourette syndrome who have tics that can be observed and studied.
- All participants must be able to undergo magnetic resonance imaging (MRI) scans.
Design:
- Healthy volunteers (two visits to the NIH Clinical Center over a 2- to 4-week period;
visit may last up to 3 hours):
- Screening visit, including physical examination and medical history, and a magnetic
resonance imaging (MRI) scan if the individual has not had one performed at the National
Institutes of Health in the past year.
- Study visit: Functional MRI (fMRI) scan to allow researchers to see if volunteers can
learn to control their brain activity during a scan. Volunteers will be asked to
complete tasks as directed during the fMRI scan.
- Patients with Tourette syndrome (three or four outpatient visits over a 4- to 6-week
period; each visit may last up to 4 hours):
- Screening visit, including physical examination and medical history, and an MRI scan if
the individual has not had one performed at the National Institutes of Health in the
past year.
- Evaluation visit to ask questions about Tourette symptoms and to have patients complete
questionnaires about their tics and their mental health.
- Study visit: fMRI scan to allow researchers to see if patients can learn to control
their brain activity during a scan. Patients will be asked to complete tasks as directed
during the fMRI scan.
- Final visit: Researchers will ask questions about tic symptoms, have patients complete
questionnaires, and perform a brief exam. Afterward, patients will have an fMRI scan
similar to the previous one.
- All participants will be paid a small amount of money in compensation for their
participation in the study.
- Many people can learn to use feedback about brain activity to modify that activity, but
is it not known if people with Tourette syndrome can modify their brain activity.
- Researchers have evidence that certain areas of the brain are involved in causing tics
in people with Tourette syndrome. If people with Tourette syndrome can use feedback
about brain activity to modify activity in those parts of the brain, they may be able to
modify their brain activity to help control the tics.
Objectives:
- To determine if people with and without Tourette syndrome can learn to use thought to
control brain activity.
- To test whether people who have Tourette syndrome can learn to control brain activities,
possibly helping to control tics.
Eligibility:
- Healthy volunteers ages 18 and older who are right-handed and are willing to not consume
caffeine or alcohol for 24 hours before the study visit.
- Patients with Tourette syndrome who have tics that can be observed and studied.
- All participants must be able to undergo magnetic resonance imaging (MRI) scans.
Design:
- Healthy volunteers (two visits to the NIH Clinical Center over a 2- to 4-week period;
visit may last up to 3 hours):
- Screening visit, including physical examination and medical history, and a magnetic
resonance imaging (MRI) scan if the individual has not had one performed at the National
Institutes of Health in the past year.
- Study visit: Functional MRI (fMRI) scan to allow researchers to see if volunteers can
learn to control their brain activity during a scan. Volunteers will be asked to
complete tasks as directed during the fMRI scan.
- Patients with Tourette syndrome (three or four outpatient visits over a 4- to 6-week
period; each visit may last up to 4 hours):
- Screening visit, including physical examination and medical history, and an MRI scan if
the individual has not had one performed at the National Institutes of Health in the
past year.
- Evaluation visit to ask questions about Tourette symptoms and to have patients complete
questionnaires about their tics and their mental health.
- Study visit: fMRI scan to allow researchers to see if patients can learn to control
their brain activity during a scan. Patients will be asked to complete tasks as directed
during the fMRI scan.
- Final visit: Researchers will ask questions about tic symptoms, have patients complete
questionnaires, and perform a brief exam. Afterward, patients will have an fMRI scan
similar to the previous one.
- All participants will be paid a small amount of money in compensation for their
participation in the study.
Objective:
The objective of this study is to see if healthy volunteers and patients with hyperkinetic
movement disorders such as Tic Disorders (TD) including Tourette Syndrome (TS) are able to
learn how to alter their brain activity using feedback during functional magnetic resonance
imaging (fMRI), and whether such feedback training can lead to improvement in symptoms in TD
patients.
Study population:
This study is to be carried out in three phases. In Phase 1 we will study the feedback
technique using fMRI with right-handed adult healthy volunteers, in Phase 2 we intend to
study if adult patients with TD are also able to learn the feedback technique, and in Phase 3
we intend to study whether feedback training with fMRI leads to improvement in symptoms in TD
patients and whether patients were able to retain the ability to alter their brain activity.
Design:
All subjects will have an initial screening visit to consent and assess their eligibility to
participate in the current study. All visits are outpatient.
Subjects will have a clinical MRI when required, a series of functional scans, and at least
one structural scan for image registration.
Phase 1: Feasibility Studies
Feasibility of fMRI neurofeedback based on activation levels.
Subjects will perform a neurofeedback fMRI visit, where they will attempt at modulating brain
activity level based on the observed feedback signal. Task include motor, motor imagery, or
mental thoughts. Functional localization of target regions will be done with a motor task or
a blink suppression paradigm. Completed.
1. Feasibility of fMRI neurofeedback based on connectivity
Subjects will perform two fMRI visits, where they will attempt to learn to modulate
their own brain connectivity using feedback of connectivity patterns between two motor
regions during a real-time fMRI paradigm. Each session will include a performance
evaluation. Data acquisition completed.
2. Feasibility of fMRI neurofeedback based on patterns
Subjects will perform one fMRI visit. A blink suppression paradigm will be used to create a
personalized model of urge . Using neurofeedback, subjects attempt to modulate the urge
pattern. In progress.
Phase 2: Pilot neurofeedback for brain modulation in TD
TD patients will have an evaluation visit, including clinical evaluations, scales and
videotaping and an fMRI visit.
In the fMRI visit, the model of urge will be created based on the brain pattern measure
before spontaneous tics. Patients will attempt towill be studied to see if they can learn to
alter their brain activity to decrease the fitting to the urge model, in a similar way as the
healthy volunteers. In progress.
Phase 3: Pilot neurofeedback fMRI for symptoms improvement in TD patients
TD patients will have one evaluation, one scanning, and one follow-up) visit. No visit will
last more than 4 hours. The effect of altering brain activity in a specific brain area on
symptoms in TD patients will be studied. Patients will be asked to continue to focus their
thoughts as they did during feedback scanning any time that they feel an urge prior to a tic
or every hour while awake, whichever is more frequent, until a follow-up visit and fMRI scan
two or three days later. Require power analysis based on Phase 2.
Outcome measures:
Primary outcomes
Phase 1
1. The difference in connectivity between two ROIs after feedback training compared to a
baseline.
2. The difference in neural pattern after feedback training compared to a baseline.
Phase 2
The difference in neural pattern after feedback training compared to a baseline.
Phase 3
The difference in symptoms measured by a TS rating scale before fMRI scanning compared to two
or three days after learning the feedback technique.
Secondary outcomes
Phase 1
1. Changes in motor performance on grooved pegboard test
2. Changes in number of blinks after a successful neurofeedback run.
Phase 2 and 3
Changes in number of tics after successful neurofeedback runs compared to baseline.
The objective of this study is to see if healthy volunteers and patients with hyperkinetic
movement disorders such as Tic Disorders (TD) including Tourette Syndrome (TS) are able to
learn how to alter their brain activity using feedback during functional magnetic resonance
imaging (fMRI), and whether such feedback training can lead to improvement in symptoms in TD
patients.
Study population:
This study is to be carried out in three phases. In Phase 1 we will study the feedback
technique using fMRI with right-handed adult healthy volunteers, in Phase 2 we intend to
study if adult patients with TD are also able to learn the feedback technique, and in Phase 3
we intend to study whether feedback training with fMRI leads to improvement in symptoms in TD
patients and whether patients were able to retain the ability to alter their brain activity.
Design:
All subjects will have an initial screening visit to consent and assess their eligibility to
participate in the current study. All visits are outpatient.
Subjects will have a clinical MRI when required, a series of functional scans, and at least
one structural scan for image registration.
Phase 1: Feasibility Studies
Feasibility of fMRI neurofeedback based on activation levels.
Subjects will perform a neurofeedback fMRI visit, where they will attempt at modulating brain
activity level based on the observed feedback signal. Task include motor, motor imagery, or
mental thoughts. Functional localization of target regions will be done with a motor task or
a blink suppression paradigm. Completed.
1. Feasibility of fMRI neurofeedback based on connectivity
Subjects will perform two fMRI visits, where they will attempt to learn to modulate
their own brain connectivity using feedback of connectivity patterns between two motor
regions during a real-time fMRI paradigm. Each session will include a performance
evaluation. Data acquisition completed.
2. Feasibility of fMRI neurofeedback based on patterns
Subjects will perform one fMRI visit. A blink suppression paradigm will be used to create a
personalized model of urge . Using neurofeedback, subjects attempt to modulate the urge
pattern. In progress.
Phase 2: Pilot neurofeedback for brain modulation in TD
TD patients will have an evaluation visit, including clinical evaluations, scales and
videotaping and an fMRI visit.
In the fMRI visit, the model of urge will be created based on the brain pattern measure
before spontaneous tics. Patients will attempt towill be studied to see if they can learn to
alter their brain activity to decrease the fitting to the urge model, in a similar way as the
healthy volunteers. In progress.
Phase 3: Pilot neurofeedback fMRI for symptoms improvement in TD patients
TD patients will have one evaluation, one scanning, and one follow-up) visit. No visit will
last more than 4 hours. The effect of altering brain activity in a specific brain area on
symptoms in TD patients will be studied. Patients will be asked to continue to focus their
thoughts as they did during feedback scanning any time that they feel an urge prior to a tic
or every hour while awake, whichever is more frequent, until a follow-up visit and fMRI scan
two or three days later. Require power analysis based on Phase 2.
Outcome measures:
Primary outcomes
Phase 1
1. The difference in connectivity between two ROIs after feedback training compared to a
baseline.
2. The difference in neural pattern after feedback training compared to a baseline.
Phase 2
The difference in neural pattern after feedback training compared to a baseline.
Phase 3
The difference in symptoms measured by a TS rating scale before fMRI scanning compared to two
or three days after learning the feedback technique.
Secondary outcomes
Phase 1
1. Changes in motor performance on grooved pegboard test
2. Changes in number of blinks after a successful neurofeedback run.
Phase 2 and 3
Changes in number of tics after successful neurofeedback runs compared to baseline.
- INCLUSION CRITERIA:
Healthy Volunteers
1. Aged 18 to 60
2. Right-hand dominant
3. Have a normal neurological exam
4. Have the capacity to give informed consent
5. Willing to abstain from caffeine and alcohol for 24 hours prior to MRI scanning
TD Patients
1. Aged 18 to 60
2. Right-dominant
3. Have TS or chronic motor or vocal tic disorder diagnosis based on neurological
examination and meeting criteria of the Diagnostic and Statistical Manual of Mental
Disorders 4th 5th Edition (DSM-V)
4. Have the capacity to give informed consent
5. A Yale Global Tic Severity Scale (YGTSS) total score of at least 5
6. Willing to abstain from caffeine and alcohol for 24 hours prior to MRI scanning
7. If pharmacologically treated for TD, willing to not alter medication dosages or
regimens between the screening visit and scanning visit for participants of Phase 2 or
between the screening visit and follow-up visit for participants of Phase 3
EXCLUSION CRITERIA:
Healthy Volunteers
1. Pregnancy
2. Any abnormal findings on neurological exam
3. Any finding on the MRI safety questionnaire that prevents them from safely undergoing
an MRI scan
4. Any medical condition that would prevent them from lying flat for up to 3 hours
5. Any history of central nervous system infection or inflammation, brain tumor, stroke,
head trauma or a vascular malformation as obtained by history or from imaging studies
6. Presence of any active or medically treated neurological conditions such as epilepsy,
multiple sclerosis, or a movement disorder
7. Presence of any active or medically treated psychiatric problems such as depression,
OCD or ADHD
8. Presence of uncontrolled medical illnesses such as heart, lung, or kidney disease
9. Presence of claustrophobia or other restriction that prevents them from undergoing a
scan in a confined space for up to 3 hours
10. Presence of continuous or excessive movements at rest or are unable to remain supine
while undergoing a scan for up to 3 hours.
TD Patients
1. Pregnancy
2. Any finding on the MRI safety questionnaire that prevents them from safely undergoing
an MRI scan
3. Any medical condition that would prevent them from lying flat for up to 3 hours
4. Any history of central nervous system infection or inflammation, brain tumor, stroke,
head trauma or a vascular malformation as obtained by history or from imaging studies
5. Presence of uncontrolled psychiatric problems such as depression, OCD or ADHD
6. Patients with a history of a psychotic disorder such as schizophrenia
7. Patients with other movement disorders or progressive neurological disorders other
than Tic disorders such as Multiple Sclerosis or epilepsy
8. Presence of uncontrolled medical illnesses such as heart, lung, or kidney disease
9. Presence of claustrophobia or other restrictions that prevent them from undergoing a
scan in a confined space for up to 3 hours
10. Presence of continuous or excessive movements at rest or are unable remain supine
while undergoing a scan for up to 3 hours
11. Presence of secondary form of tic disorder
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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