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Thalamic Deep Brain Stimulation for Tourette Syndrome

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ClinicalTrials.gov Identifier: NCT03958617
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Jens Kuhn, University of Cologne

Brief Summary:
In this single-center trial, we aim to include 8 patients with severe and medically refractory Tourette's syndrome. All patients undergo deep brain stimulation surgery with two electrodes located in the centromedian-parafascicular complex. Tic severity and secondary outcome measurements are assessed six and twelve months after surgery. Additionally, a short randomized, double-blinded sham controlled crossover sequence of 24 to 48 hours in either active or sham stimulation is implemented after both 6 and 12 months assesments. Subjects and clinicians are blinded to treatment allocation.

Condition or disease Intervention/treatment Phase
Tourette Syndrome Device: Bilateral Deep brain stimulation of the thalamus, Medtronic Device Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A pragmatic trial with brief randomized, double-blinded sham controlled sequences
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thalamic Deep Brain Stimulation for Tourette's Syndrome: a Pragmatic Trial With Brief Randomized, Double-blinded Sham Controlled Sequences
Actual Study Start Date : May 1, 2014
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: On condition
Ongoing thalamic deep brain stimulation
Device: Bilateral Deep brain stimulation of the thalamus, Medtronic Device
Sham Comparator: Off condition
Switched off thalamic deep brain stimulation, sham stimulation
Device: Bilateral Deep brain stimulation of the thalamus, Medtronic Device



Primary Outcome Measures :
  1. Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Change in the YGTSS Scale from Baseline to 6 and 12 months ]

    Motor tic subscore range 0-25 Vocal tic scubscore range 0-25 Impairment range0-50 Total Score (Vocal tic score + Motor tic score + Impairment) range 0-100

    Higher Scores indicate higher tic severity, thus worse outcome



Secondary Outcome Measures :
  1. Modified Rush video rating scale (MRVRS) [ Time Frame: Change in the MRVRS Scale from Baseline to 6 and 12 months ]

    Range 0-20

    Higher Scores indicate higher tic severity, thus worse outcome




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Das Tourette-Syndrom (ICD-10: F 95.2; DSM IV: 307.23) als Hauptdiagnose. Bei dem Patienten ist aufgrund einer chronischen, schwergradigen und therapieresistenten Verlaufsform des TS eine Behandlung mittels THS thalamischer Strukturen im Sinne einer ultima ratio vorgesehen.
  • Alter des Patienten 18 bis 65 Jahre
  • Sicher im Verstehen der deutschen Sprache
  • Unterzeichnete Einverständniserklärung

Exclusion Criteria:

  • Klinisch manifeste Psychose
  • Schwangerschaft und Stillzeit
  • Unterbringung nach PsychKG
  • Kontraindikationen einer MRT-Untersuchung wie z. B. implantierter Herzschrittmacher / Defibrillator
  • Neoplastische neurologische Erkrankungen
  • Kontraindikationen einer stereotaktischen Operation, wie z. B.: erhöhte Blutungsneigung, cerebrovaskuläre Erkrankungen (z. B. arteriovenöse Malformationen, Aneurysmata, systemische Gefäßerkrankungen, die auf das Cerebrum übergreifen).
  • Teilnahme an einer anderen klinischen Studie
  • Hirnassoziierte Kriterien, die eine OP ausschließen (Gefäßanomalien, große arteriovenöse Malformationen, Hirnmetastasen, Neoplasien des ZNS (Ausnahme asymptomatisches inzidentielles Meningeom))
  • Antikoagulationtherapie, die in der perioperativen Phase nicht ausgesetzt werden kann
  • OP am Gehirn in der Anamnese, die mit der Platzierung/Funktion des MP interferieren
  • Med. Gegebenheiten, die mit der Studienprozedur interferieren oder Evaluation der Studienparameter beeinträchtigen inkl. Erkrankungen im terminalen Stadium (Lebenserwartung < 12 Monate)
  • Akute Suizidalität
  • Abhängigkeit von Alkohol oder Drogen (exklusive Cannabis, da es von schwer betroffenen Patienten teilweise zur Ticreduktion im Sinne einer Selbstmedikation eingesetzt wird sowie exklusive Opioide und Benzodiazepine, wenn diese initial zur Ticreduktion im Sinne einer Selbstmedikation eingesetzt wurden)
  • Klinisch relevante internistische oder neurologische Erkrankungen
  • Intelligenzminderung
  • Alle aktiv implantierten Medizinprodukte
  • Schweres Schädel-Hirn-Trauma in der Anamnese
  • Metallimplantate im Kopfbereich ( Bsp. Aneurysmaclips)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958617


Locations
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Germany
University of Cologne
Cologne, Germany, 50924
Sponsors and Collaborators
University of Cologne
German Research Foundation
Investigators
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Principal Investigator: Jens Kuhn, MD University Hospital of Cologne

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Responsible Party: Jens Kuhn, P.I., University of Cologne
ClinicalTrials.gov Identifier: NCT03958617     History of Changes
Other Study ID Numbers: 1648
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tourette Syndrome
Syndrome
Disease
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders