A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01647269
Study type	Interventional
Source	University College, London
Contact
Status	Completed
Phase	Phase 2
Start date	July 2011
Completion date	November 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04851678` - Longitudinal Impact of Stressors in Adults With Tourette Syndrome
Completed	`NCT02605902` - Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders	N/A
Completed	`NCT04007913` - Incorporating teleCBIT Into a Hospital-Based Tic Program	N/A
Completed	`NCT02900144` - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)	N/A
Completed	`NCT02216474` - Brain Stimulation in Movement Disorders	N/A
Completed	`NCT02256475` - Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome	Phase 1
Completed	`NCT01329198` - Brain Stimulation for the Treatment of Tourette Syndrome	N/A
Terminated	`NCT00952601` - Pilot Study of the Modified Atkins Diet for Tourette Syndrome	Phase 1
Enrolling by invitation	`NCT00355927` - Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.	N/A
Completed	`NCT00206323` - A Randomized, Placebo-controlled, Tourette Syndrome Study.	Phase 3
Completed	`NCT00004376` - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder	Phase 3
Completed	`NCT04498364` - Extinction Learning in Adults With Tourette Syndrome	N/A
Completed	`NCT00755339` - Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
Completed	`NCT03325010` - Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome	Phase 2
Not yet recruiting	`NCT06081348` - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders	Phase 2
Completed	`NCT01719523` - Open-Trial of EPI-743 for Adults With Tourette Syndrome	Phase 1
Completed	`NCT01702077` - Neurofeedback for Tourette Syndrome	N/A
Completed	`NCT00231985` - Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder	Phase 2
Completed	`NCT00206336` - An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.	Phase 3
Terminated	`NCT03732534` - Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms