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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH095789 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The aim of this study is to train patients with tic disorders to control activity in a region of their brain that has been associated with the urge to tic. Patients will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control activity in the region during these feedback sessions. In separate sessions, patients will be given sham feedback based on the brain patterns of a prior subject rather than their own brain patterns. Our primary hypothesis is that the biofeedback training will reduce their tic symptoms more than the sham feedback.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback first | Experimental | Neurofeedback then sham feedback |
|
| Sham first | Experimental | Sham feedback then neurofeedback |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Tic severity | A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity. | Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback. |
| Tic severity | A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity. | Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback. |
| Measure | Description | Time Frame |
|---|---|---|
| Control over target brain area | Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area. | Assessed approximately half a week BEFORE biofeedback/sham biofeedback. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional connectivity patterns in the brain | Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data. | Assessed approximately half a week BEFORE biofeedback/sham biofeedback. |
| Functional connectivity patterns in the brain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Hampson, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D013981 | Tic Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| Sham feedback | Procedure |
|
| Control over target brain area | Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area. | Assessed approximately half a week AFTER biofeedback/sham biofeedback. |
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data. |
| Assessed approximately half a week AFTER biofeedback/sham biofeedback. |
| Clinical improvement | The Clinical Global Impression - Improvement scale will be used to assess improvement over the course of the biofeedback/sham feedback | Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |