Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome

NCT01817517 | Terminated Results DMC

• 1 other identifier: NA_00073086
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Yale Global Tic Severity Scale (YGTSS)

  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.

  1 year after neurostimulator implantation

• Number of Participants Free of Adverse Device Effects (ADEs).

  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.

  1 year after neurostimulator implantation.

Secondary Outcomes (2)

• Change From Baseline in the Yale-Brown Obsessive Compulsive Scale

  1 year after neurostimulator implantation.

• Change From Baseline in the WHO Adult ADHD Self-Report Scale (ASRS)

  1 year after neurostimulator implantation.

Other Outcomes (6)

• Change From Baseline in the Grooved Pegboard Test

  1 year after neurostimulator implantation.

• Change From Baseline in the Judgement of Line Orientation

  1 year after neurostimulator implantation.

• Change From Baseline in the Trailmaking Test - A

  1 year after neurostimulator implantation.

Study Arms (1)

Deep Brain Stimulation implant

EXPERIMENTAL

Unblinded treatment arm, thalamic DBS for Tourette syndrome.

Device: Medtronic Activa Deep Brain Stimulation System

Interventions

Medtronic Activa Deep Brain Stimulation System DEVICE

Deep Brain Stimulation implant

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subject has a diagnosis of TS as determined by a review of medical records, discussion with referring psychiatrist as well as the DSM-IV criteria and videotaped assessment. This will include an assessment to determine the presence of psychogenic tics, embellishment, factitious symptoms, personality disorders and malingering.
• Subject determined to be treatment-resistant for at least one year prior to the Screening Visit as demonstrated by clinical evidence (determined by review of medical records and discussion with referring psychiatrist or neurologist) of persistent functionally impairing tics that have not responded to treatment with a minimum of three adequate regimens of medication including two failed trials of at least one typical neuroleptic and one atypical neuroleptic medication, along with one failed trial of a first tier medication as defined as follows:
• Adequate trials of one non-neuroleptic medication including drugs from the following (first tier) list: clonidine, guanfacine, topiramate, baclofen, levetiracetam, and clonazepam. Trial failure is defined as demonstrated lack of efficacy or severe side effects.
• Two adequate trials of at least one typical neuroleptic medication (pimozide, fluphenazine, haloperidol) and at least one atypical neuroleptic (risperidone, aripiprazole, ziprasidone, olanzapine, quetiapine). Trial failure is defined as demonstrated lack of efficacy or severe side effects.
• A mandatory trial of behavioral interventions in an attempt to reduce the severity of the tics or comorbid symptoms must also be completed by the subject before offering participation in this trial. This may include habit reversal therapies, stress reduction therapies, or other behavioral therapies under investigation for tic suppression.
• Subject has both significant vocal and motor tics with a tic subscale score of at least 35 on the YGTSS (Yale Global Tic Severity Scale) at all three Baseline Visits prior to undergoing surgery. For subjects with predominantly vocal tics (and minimal motor) causing significant problems this score requirement will be reduced to 18, similarly for subjects with predominantly motor tics (and minimal vocal) causing significant problems the required score will be 18. A portion of the study team, including the surgeon and two neurologists, will determine by consensus which category the subject falls into and whether the tics are a significant problem.
• All other aspects of the subject's care must be optimized during the preceding 6 months before admission to the study. This includes treatment for comorbid medical, neurological, and psychiatric disorders. Additionally, it includes psychological interventions for any ongoing psychosocial problems the subject may have during the preceding 6 months before study admission.
• Subject must be ambulatory.
• Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or intrauterine device \[IUD\]). If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained at baseline Visits 1 and 3.
• Subject is determined by an independent psychiatrist with expertise in capacity assessments to have decision-making capacity to provide informed consent.
• Subject is able to read English, understand and cooperate with study procedures, and has signed a written informed consent form prior to any study procedures.
• Subject has a positive urine drug screen at any of the three Baseline Visits.
• Subject had major surgery within three months prior to Baseline Visit 1 or has other surgery planned during the proposed study period.
• Subject is determined by medical consultant to have medical contraindications to undergoing surgery.
• Subject is pregnant or breast-feeding.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

The study had recruitment limitations (both screened for consideration and implantations), partly due to staffing and administrative issues, which hampered analysis at a group level. Therefore, individual results were reported.

Results Point of Contact

• Title: Ankur Butala MD
• Organization: Johns Hopkins Medicine

Ankur.Butala@jhmi.edu

410-502-0133

Study Officials

• Ankur Butala, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 25, 2013
• Study Start: March 1, 2014
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Locations

US (1)