Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2012-10-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sham first
Sham feedback then neurofeedback
Neurofeedback
Sham feedback
Neurofeedback first
Neurofeedback then sham feedback
Neurofeedback
Sham feedback
Interventions
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Neurofeedback
Sham feedback
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* currently active tics
* aged 11-19
* ability to execute most common tics without moving head while lying on back
Exclusion Criteria
* Lifetime diagnosis of pervasive developmental disorder, bipolar disorder, or psychotic disorder.
* Presence of any serious psychiatric or psychosocial condition requiring initiation of new treatment or change in current treatment.
* Neurological conditions affecting central nervous system, with the exception that predisposition to migraine will not be grounds for exclusion
* Change in medication in the month prior to beginning the study
* Unwillingness to keep medication stable over the course of the intervention
* Full braces (but some retainers are OK)
* Claustrophobia of a degree that they cannot comfortably be scanned
* If common tics involve dramatic changes in breathing that could alter blood oxygenation measurements
* Inability to keep head still while executing most common tics
* Inability to keep head still in mock scanner
* Inability or unwillingness to understand or follow the instructions
* Pregnancy or possible pregnancy
* Subjects may also be excluded after the first magnetic resonance scan if we are unable to localize a region of their supplementary motor area involved in tics - leaving us without a target area for biofeedback.
11 Years
19 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Michelle Hampson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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Other Identifiers
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0206017435
Identifier Type: -
Identifier Source: org_study_id
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