Clinical Trials Logo

Clinical Trial Summary

Within an ongoing deep brain stimulation (DBS) program for Tourette syndrome (TS) at the Department of Neurology, Pitié-Salpêtrière Hospital, Paris/France, the investigator team plans to evaluate patients pre-operatively and then at one year intervals post-operatively until the 5-year mark has been achieved. The investigator team will investigate tic severity, psychiatric co-morbidities, quality of life, and neuropsychological measures.


Clinical Trial Description

Since the completion of the STIC trial in 2017, the french team continues to offer DBS of the globus pallidus internus (GPi) to selected, treatment-refractory patients with TS. On average, three to four patients undergo surgery every year. Even though a first follow-up of the STIC cohort up to four years post-op indicates ongoing improvement of tic severity, many questions remains regarding the efficacy of GPi DBS in TS. These questions include frequent comorbidities of TS, quality of life, evolution of medication and stimulation parameters, as well as neuropsychological functioning. Therefore, the investigator proposes to evaluate all patients undergoing GPi DBS for TS to be evaluated comprehensively pre-operatively and once yearly after surgery until reaching the 5-year mark. The investigator team hopes these data may help to plan for future international multicenter trials, and provide indications on prognostic factors concerning response to GPi DBS in TS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04449068
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact Andreas HARTMANN, MD
Phone 1 42 16 13 16
Email andreas.hartmann@aphp.fr
Status Recruiting
Phase
Start date January 12, 2021
Completion date June 12, 2031

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