Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders

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Brief Title

Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders

Official Title

Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

Phase 1 & 2: Difference in BOLD signal in a ROI during neurofeedback after training compared to resting baseline. Phase 3: Change in YGTSS measured prior to neurofeedback training compared to the score measured at a follow-up visit.

Secondary Outcome

 Difference in BOLD signal in a ROI during neurofeedback compared to a resting baseline after subsequent scanning runs and during a transfer task, and in Phase 3 compared to controls. Also any changes of neurofeedback on various disease measures...

Condition

Movement Disorder



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

59

Start Date

April 17, 2009

Completion Date

June 20, 2019


Eligibility Criteria

        -  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
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Silvina G Horovitz, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00885040

Organization ID

090118

Secondary IDs

09-N-0118

Responsible Party

Sponsor

Study Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)


Study Sponsor

Silvina G Horovitz, Ph.D., Principal Investigator, National Institute of Neurological Disorders and Stroke (NINDS)


Verification Date

June 20, 2019