Tourette Syndrome
Conditions
Keywords
Tourette Syndrome, Deep Brain Stimulation, Video assessment, YGTSS, TSSL
Brief summary
The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.
Interventions
DEVICEThalamic deep brain stimulation
Sponsors
Medtronic
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 or older * Diagnosis of Tourette Syndrome by DSM-IV * Tic frequency at least one per minute at screening * prior failure of at least two dopamine receptor or presynaptic blockers * negative impact on quality of life
Exclusion criteria
* significant structural brain lesion (on imaging studies) * significant dementia * severe head trauma preceding onset of tics * use of dopamine receptor blockers prior to recognition of tics * prior implanted electrical device * electroconvulsive therapy (ECT) within 24 months * suicide attempt within 12 months * significant sociopathic personality * current or planned pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified Rush Video Rating Scale (mRVRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Yale Global Tourette Severity Scale (YGTSS) | — |
| Tourette Syndrome Symptom List (TSSL) | — |
| tic counts (on video recording) | — |
| SF-36 | — |
| Neuropsychological battery | — |
| Quality of Life Visual Analog Scale (VAS) | — |
Countries
United States
Outcome results
None listed