Tourette SyndromePhase 2/3NCT03958617
Thalamic Deep Brain Stimulation for Tourette Syndrome
A Phase 2/3 study testing Bilateral Deep brain stimulation of the thalamus, Medtronic Device in people with Tourette Syndrome, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Bilateral Deep brain stimulation of the thalamus, Medtronic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2014to 31 Mar 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tourette Syndrome
- Being tested
- Bilateral Deep brain stimulation of the thalamus, Medtronic Device
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Deep brain stimulation of the thalamus, Medtronic DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| On condition | Active comparator | Ongoing thalamic deep brain stimulation Receives: Device: Bilateral Deep brain stimulation of the thalamus, Medtronic Device |
| Off condition | Sham comparator | Switched off thalamic deep brain stimulation, sham stimulation Receives: Device: Bilateral Deep brain stimulation of the thalamus, Medtronic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Global Tic Severity Scale (YGTSS)
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
Measured: Change in the YGTSS Scale from Baseline to 6 and 12 months
Secondary outcomes (1)
Modified Rush video rating scale (MRVRS)
Range 0-20
Higher Scores indicate higher tic severity, thus worse outcome
Measured: Change in the MRVRS Scale from Baseline to 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 May 2014
- Primary completion28 Feb 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A pragmatic trial with brief randomized, double-blinded sham controlled sequences
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Jens Kuhn, University of Cologne
- Investigators
- Jens Kuhn, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958617
- Sponsor's protocol ID
- 1648
- Status last verified
- May 2019
- First submitted
- 26 Jun 2017
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalamic Deep Brain Stimulation for Tourette's Syndrome: a Pragmatic Trial With Brief Randomized, Double-blinded Sham Controlled Sequences
- ClinicalTrials.gov ID
- NCT03958617
- Acronym / sponsor ID
- 1648
- Conditions
- Tourette Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 May 2014 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic trial with brief randomized, double-blinded sham controlled sequences
| Arm | Type | Receives |
|---|---|---|
| On condition | Active comparator | Device: Bilateral Deep brain stimulation of the thalamus, Medtronic DeviceOngoing thalamic deep brain stimulation |
| Off condition | Sham comparator | Device: Bilateral Deep brain stimulation of the thalamus, Medtronic DeviceSwitched off thalamic deep brain stimulation, sham stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- Klinisch manifeste Psychose
- Schwangerschaft und Stillzeit
- Unterbringung nach PsychKG
- Kontraindikationen einer MRT-Untersuchung wie z. B. implantierter Herzschrittmacher / Defibrillator
- Neoplastische neurologische Erkrankungen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Deep brain stimulation of the thalamus, Medtronic Device | Device | Off condition, On condition |
Primary outcome
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
1 secondary outcome
Modified Rush video rating scale (MRVRS)
Time frame: Change in the MRVRS Scale from Baseline to 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: No
Related trials for Tourette Syndrome
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Kuhn, MD principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bilateral Deep brain stimulation of the thalamus, Medtronic Device in people with Tourette Syndrome, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Global Tic Severity Scale (YGTSS) (time frame: Change in the YGTSS Scale from Baseline to 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.