Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome

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Brief Title

Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome

Official Title

Phase 1 Study of Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome

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.
    



Study Type

Interventional


Primary Outcome

Change from baseline in the Yale Global Tic Severity Scale (YGTSS)

Secondary Outcome

 Change from baseline in the Yale-Brown Obsessive Compulsive Scale

Condition

Tourette Syndrome

Intervention

Medtronic Activa Deep Brain Stimulation System

Study Arms / Comparison Groups

 Deep Brain Stimulation implant
Description:  Unblinded treatment arm, thalamic DBS for Tourette syndrome.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

March 2014

Completion Date

April 2031

Primary Completion Date

April 2030

Eligibility Criteria

        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 Exclusion Criteria). For subjects in the age range of 15-24 years, an additional
             Ethics Committee consultation will be obtained prior to offering the subject the
             required screening visit. This is based on the revised screening criteria now proposed
             by Shrock, Mink, et al. on studies investigating DBS in TS. Additionally, for subjects
             in the age range of 15-20, a caregiver will be required to be present for all study
             visits.

          2. 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.

          3. 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:

               1. 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.

               2. 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.

          4. 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.

          5. 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.

          6. 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.

          7. Subject must be ambulatory.

          8. 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.

          9. Subject is determined by an independent psychiatrist with expertise in capacity
             assessments to have decision-making capacity to provide informed consent.

         10. 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.

        Exclusion Criteria:

          1. Subject has a positive urine drug screen at any of the three Baseline Visits.

          2. Subject had major surgery within three months prior to Baseline Visit 1 or has other
             surgery planned during the proposed study period.

          3. Subject is determined by medical consultant to have medical contraindications to
             undergoing surgery.

          4. Subject is pregnant or breast-feeding.

          5. Subject has a history of alcohol or drug abuse within the past 6 months and/or
             dependence within the past year.

          6. Subject has a medical illness/condition, and/or abnormal diagnostic finding that would
             interfere with the completion of the study, confound the results of the study, or pose
             risk to the patient.

          7. Subject has an untreated or uncontrolled Axis I disorder or other major psychiatric
             disorder including major depression, bipolar disorder, or schizophrenia as determined
             by the screening psychiatrist.

          8. Subject has either a current or past history of suicidal plan and/or intent.

          9. Subject has a tic disorder or other movement disorder attributable to another medical,
             neurological, or psychiatric disorder other than Tourette Syndrome.

         10. Subject has a drug-induced tic disorder.

         11. Subject has significant psychosocial factors that might increase the risk of the DBS
             procedure or complicate recovery and outcome assessments. (Examples include - history
             of noncompliance with previous medical and psychosocial treatments, multiple failed
             medication treatments of inadequate dose or duration, a history of multiple other
             surgical procedures with poor outcome, unexplained medical history gaps, or pending
             lawsuits or other legal action.)

         12. Subject has metal in the head or any other type of implanted stimulator (i.e. cardiac
             pacemaker, deep brain stimulator for a different disease, spinal cord stimulator,
             cochlear implant, vagus nerve stimulator, etc.).

         13. Subject has participated in another investigational drug trial or therapeutic trial
             within 30 days of Baseline Visit 1.

         14. Subject has a diagnosis of intellectual disability with documented IQ<70.

         15. Subject has a neurological condition, or a history of traumatic brain injury
             associated with loss of consciousness of > 1 hour and/or
             intracranial/epidural/subdural bleeding.
      

Gender

All

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shannon L Dean, MD, PhD, 4439234100, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01817517

Organization ID

NA_00073086


Responsible Party

Sponsor

Study Sponsor

Johns Hopkins University


Study Sponsor

Shannon L Dean, MD, PhD, Principal Investigator, The Johns Hopkins University School of Medicine, Kennedy Krieger Institute


Verification Date

May 2021