Tourette SyndromePhase 2NCT00311909
Thalamic Deep Brain Stimulation for Tourette Syndrome
A Phase 2 study testing Thalamic deep brain stimulation in people with Tourette Syndrome, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Thalamic deep brain stimulation
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Apr 2006
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or older
- Diagnosis of Tourette Syndrome by DSM-IV
- Tic frequency at least one per minute at screening
- prior failure of at least two dopamine receptor or presynaptic blockers
- negative impact on quality of life
Who cannot join
- significant structural brain lesion (on imaging studies)
- significant dementia
- severe head trauma preceding onset of tics
- use of dopamine receptor blockers prior to recognition of tics
- prior implanted electrical device
- electroconvulsive therapy (ECT) within 24 months
Show all 9Show fewer
- suicide attempt within 12 months
- significant sociopathic personality
- current or planned pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial
The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.
- Conditions
- Tourette Syndrome
- Being tested
- Thalamic deep brain stimulation
- Keywords
- Tourette Syndrome, Deep Brain Stimulation, Video assessment, YGTSS, TSSL
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalamic deep brain stimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rush Video Rating Scale (mRVRS)
Secondary outcomes (6)
tic counts (on video recording)
Yale Global Tourette Severity Scale (YGTSS)
Tourette Syndrome Symptom List (TSSL)
Quality of Life Visual Analog Scale (VAS)
SF-36
Neuropsychological battery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startJun 2005
- Primary completionApr 2006
- Study completionApr 2006
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Robert J Maciunas, MD MPH FACS, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311909
- Sponsor's protocol ID
- UHC DBS TS
- Status last verified
- May 2022
- First submitted
- 5 Apr 2006
- Last updated
- 12 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT00311909
- Acronym / sponsor ID
- UHC DBS TS
- Conditions
- Tourette Syndrome
- Keywords
- Tourette Syndrome, Deep Brain Stimulation, Video assessment, YGTSS, TSSL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 6 Apr 2006 (estimated)
- 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.
The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 or older
- Diagnosis of Tourette Syndrome by DSM-IV
- Tic frequency at least one per minute at screening
- prior failure of at least two dopamine receptor or presynaptic blockers
- negative impact on quality of life
Key exclusion criteria (9 listed)
- significant structural brain lesion (on imaging studies)
- significant dementia
- severe head trauma preceding onset of tics
- use of dopamine receptor blockers prior to recognition of tics
- prior implanted electrical device
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 |
|---|---|---|
| Thalamic deep brain stimulation | Device | – |
Primary outcome
modified Rush Video Rating Scale (mRVRS)
6 secondary outcomes
tic counts (on video recording)
Yale Global Tourette Severity Scale (YGTSS)
Tourette Syndrome Symptom List (TSSL)
Quality of Life Visual Analog Scale (VAS)
SF-36
Neuropsychological battery
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 12 May 2022.
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.
Robert J Maciunas, MD MPH FACS principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalamic deep brain stimulation in people with Tourette Syndrome, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 5 inclusion and 9 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 12 May 2022. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
modified Rush Video Rating Scale (mRVRS). 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 12 May 2022.