A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01647269
First received: July 16, 2012
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to investigate whether deep brain stimulation (DBS) of the globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS) and whether this treatment has any influence on social, psychological and behavioral disability and quality of life.


Condition Intervention Phase
Tourette Syndrome
Procedure: Bilateral GPi Deep Brain Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Controlled, Crossover Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Severe Tourette Syndrome

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Change in Yale Global Tic Severity Scale [ Time Frame: Three months after stimulation switched ON v three months after stimulation switched OFF ] [ Designated as safety issue: No ]
    The Change in Scores on the Yale Global Tic Severity Scale will be compared between defined periods with stimulation switched ON v stimulation switched OFF.


Secondary Outcome Measures:
  • Change in Modified Rush Video Rating scale [ Time Frame: Three months after stimulation switched ON v three months after stimulation switched OFF ] [ Designated as safety issue: No ]
  • Change in Yale Brown Obsessive Compulsive Scale [ Time Frame: Three months after stimulation switched ON v three months after stimulation switched OFF ] [ Designated as safety issue: No ]
  • Change in Neuropsychiatric Inventory [ Time Frame: Three months after stimulation switched ON v three months after stimulation switched OFF ] [ Designated as safety issue: No ]
  • Change in Tourette Quality of life scale [ Time Frame: Three months after stimulation switched ON v three months after stimulation switched OFF ] [ Designated as safety issue: No ]
  • Change in MOVES scale [ Time Frame: Three months after stimulation switched ON v three months after stimulation switched OFF ] [ Designated as safety issue: No ]
  • Change in Beck Depression Inventory [ Time Frame: Three months after stimulation switched ON v three months after stimulation switched OFF ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBS Off first Procedure: Bilateral GPi Deep Brain Stimulation
Bilateral GPi Deep Brain Stimulation
Experimental: DBS On First Procedure: Bilateral GPi Deep Brain Stimulation
Bilateral GPi Deep Brain Stimulation

Detailed Description:

This study is aimed at adults who have severe Tourette syndrome and who have found that conventional treatments, such as drugs, do not control their symptoms sufficiently or cannot be tolerated.

The first two clinic visits will involve assessments. Participants will fill in a number of questionnaires and be examined by a psychiatrist and a neurologist. At the second visit, the patient will provide consent for participation and will undergo formal tests to find out if the participant is suitable and willing to undergo the research study and to record the type and severity of their Tourette syndrome symptoms.

The third visit will be an admission to hospital to have the deep brain stimulation (DBS) devices implanted. The admission to hospital should be around five days in duration.

At the first post operative follow-up visit, the patient will be placed into a "stimulator on" group or a "stimulator off" group. To try and make sure that these groups are the same to start with, each patient is put into a group by chance (randomly). This visit will take place around six weeks after surgery. In this trial, the participant will have an equal chance of being in the "on" or the "off" group first. This trial is also a "blinded" trial, neither the patient nor the researchers performing the assessments will know which group the patient is in.

At the next visit, 3 months later, the patient will have a further assessment. If their stimulators have been "on" for the first 3 months, they will be switched off. If they have been "off" they will be switched on.

At the next visit, 3 months later, the patient will be assessed again and then given the opportunity to carry on the trial with the stimulators switched on for long term follow up.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The participant must be adult with stable Tourette syndrome.
  2. The participant must have a chronic and severe tic disorder with severe functional impairment, with a Yale Tourette Severity Scale score of at least 35/55 for at least 12 months prior to surgery.
  3. The participant must have failed conventional medical treatment at therapeutic doses of three classes of medication.
  4. The participant must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful.
  5. The participant must have been on stable and optimised treatment of co-morbid conditions for at least 6 months.
  6. The participant must be actively involved with and compliant with any psychosocial interventions.
  7. The patient must be compliant with treatment plans.

Exclusion Criteria:

  1. The tic disorder is attributable to any other condition.
  2. Any other medical or psychiatric disorders that substantially increase the risk of a failed procedure or that would significantly impede recovery.
  3. Psychosocial factors which might impede operative and post-operative care and research participation.
  4. Coagulation problems
  5. Other disease compromising life expectancy
  6. Patient likely to benefit from psychological intervention
  7. Patient unwilling to co-operate with post operative assessment and care
  8. Pregnancy.
  9. Participant under 20 years old.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647269

Locations
United Kingdom
UCL Institute of Neurology
London, United Kingdom
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Thomas Foltynie, MBBS PhD UCL Institute of Neurology
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01647269     History of Changes
Other Study ID Numbers: UCL 11/0226
Study First Received: July 16, 2012
Last Updated: August 28, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Syndrome
Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Disease
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Mental Disorders Diagnosed in Childhood
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes
Tic Disorders

ClinicalTrials.gov processed this record on October 21, 2014