Tourette Syndrome
Conditions
Brief summary
This research is being performed to try to understand if the use of deep brain stimulation or DBS can treat the symptoms of Tourette syndrome that do not respond well to current medications. In order to do this the investigators will place small stimulation leads on both sides of the brain in a region (a portion of the thalamus) that may alter the abnormal activity in the brain contributing to the symptoms of Tourette syndrome. This requires two surgical procedures, and several preoperative and postoperative visits for tuning the stimulation parameters and recording stimulation effects. The FDA has not approved DBS for use in people with Tourette syndrome, and Medtronic (the manufacturer of the device) has not conducted testing for the system in Tourette syndrome. Therefore its use in this study is experimental.
Interventions
DEVICEMedtronic Activa Deep Brain Stimulation System
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females who are \>=15 years of age. There is no strict age cutoff at the upper limit of inclusion, however subjects may meet the
Exclusion criteria
based on medical contraindications to deep brain stimulation surgery (Points 3. and 6. under the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) | 1 year after neurostimulator implantation | Investigators will assess deep brain stimulation effects on tic frequency and severity using the change in Yale Global Tic Severity Scale (YGTSS) in this population of Tourette syndrome patients. The scales range from 0-100, higher scores indicate greater tic severity and impairment. |
| Number of Participants Free of Adverse Device Effects (ADEs). | 1 year after neurostimulator implantation. | We will assess the incidence of adverse device effects (ADEs) as defined by the Code of Federal Regulations (21 CFR 812.3) at 1 year. Number of participants free of adverse events by 1year post implantation is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Yale-Brown Obsessive Compulsive Scale | 1 year after neurostimulator implantation. | We will assess deep brain stimulation effects on obsessive compulsive disorder symptoms using the Yale-Brown Obsessive Compulsive Scale (Baseline score - Final score). Score range 0-40, higher scores indicate greater severity of OCD symptoms. |
| Change From Baseline in the WHO Adult ADHD Self-Report Scale (ASRS) | 1 year after neurostimulator implantation. | We will assess deep brain stimulation effects on ADHD symptoms as measured by the WHO Adult ADHD Self-Report Scale (ASRS). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnkur Butala, MD
Johns Hopkins University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Grooved Pegboard Test - Dominant Hand Subject 1 | 80 seconds |
| Grooved Pegboard Test - Dominant Hand Subject 2 | 58.5 seconds |
| Hopkins Verbal Learning Test - Delayed Free Recall Subject 1 | 2 items recalled |
| Hopkins Verbal Learning Test - Delayed Free Recall Subject 2 | 12 items recalled |
| Judgement of Line Orientation Subject 1 | 13 score on a scale |
| Judgement of Line Orientation Subject 2 | 27 score on a scale |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
| Time on Trail Making Test (TMT- A) Subject 1 | 40 seconds |
| Time on Trail Making Test (TMT- A) Subject 2 | 14 seconds |
| Time on Trail Making Test (TMT-B) Subject 1 | 480 seconds |
| Time on Trail Making Test (TMT-B) Subject 2 | 25 seconds |
| Verbal Fluency Test (COWAT) Subject 1 | 11 total # of words (FAS) |
| Verbal Fluency Test (COWAT) Subject 2 | 46 total # of words (FAS) |
| WHO Adult ADHD Self-Report Scale (ASRS) Subject 1 | 5 units on a scale |
| WHO Adult ADHD Self-Report Scale (ASRS) Subject 2 | 4 units on a scale |
| Yale Brown Obsessive Compulsive Score Subject 1 | 0 units on a scale |
| Yale Brown Obsessive Compulsive Score Subject 2 | 19 units on a scale |
| Yale Global Tic Severity Scale (YGTSS) Total Score Subject 1 | 68 units on a scale |
| Yale Global Tic Severity Scale (YGTSS) Total Score Subject 2 | 71 units on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
None listed