Thalamic Deep Brain Stimulation for Tourette Syndrome

May 21, 2019 updated by: Jens Kuhn, University of Cologne

Thalamic Deep Brain Stimulation for Tourette's Syndrome: a Pragmatic Trial With Brief Randomized, Double-blinded Sham Controlled Sequences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50924
        • University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change in the YGTSS Scale from Baseline to 6 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change in the MRVRS Scale from Baseline to 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cologne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jens Kuhn, MD, University Hospital of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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