Tourette SyndromePhase 2NCT01647269
A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome
A Phase 2 study testing Bilateral GPi Deep Brain Stimulation in people with Tourette Syndrome, run by University College, London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether deep brain stimulation (DBS) of the globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS) and whether this treatment has any influence on social, psychological and behavioral disability and quality of life. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Bilateral GPi Deep Brain Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Nov 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant must be adult with stable Tourette syndrome.
- The participant must have a chronic and severe tic disorder with severe functional impairment, with a Yale Tourette Severity Scale score of at least 35/55 for at least 12 months prior to surgery.
- The participant must have failed conventional medical treatment at therapeutic doses of three classes of medication.
- The participant must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful.
- The participant must have been on stable and optimised treatment of co-morbid conditions for at least 6 months.
- The participant must be actively involved with and compliant with any psychosocial interventions.
- The patient must be compliant with treatment plans.
Who cannot join
- The tic disorder is attributable to any other condition.
- Any other medical or psychiatric disorders that substantially increase the risk of a failed procedure or that would significantly impede recovery.
- Psychosocial factors which might impede operative and post-operative care and research participation.
- Coagulation problems
- Other disease compromising life expectancy
- Patient likely to benefit from psychological intervention
Show all 9Show fewer
- Patient unwilling to co-operate with post operative assessment and care
- Pregnancy.
- Participant under 20 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Controlled, Crossover Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Severe Tourette Syndrome
The purpose of this study is to investigate whether deep brain stimulation (DBS) of the globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS) and whether this treatment has any influence on social, psychological and behavioral disability and quality of life.
Read the detailed description
This study is aimed at adults who have severe Tourette syndrome and who have found that conventional treatments, such as drugs, do not control their symptoms sufficiently or cannot be tolerated.
The first two clinic visits will involve assessments. Participants will fill in a number of questionnaires and be examined by a psychiatrist and a neurologist. At the second visit, the patient will provide consent for participation and will undergo formal tests to find out if the participant is suitable and willing to undergo the research study and to record the type and severity of their Tourette syndrome symptoms.
The third visit will be an admission to hospital to have the deep brain stimulation (DBS) devices implanted. The admission to hospital should be around five days in duration.
At the first post operative follow-up visit, the patient will be placed into a "stimulator on" group or a "stimulator off" group. To try and make sure that these groups are the same to start with, each patient is put into a group by chance (randomly). This visit will take place around six weeks after surgery. In this trial, the participant will have an equal chance of being in the "on" or the "off" group first. This trial is also a "blinded" trial, neither the patient nor the researchers performing the assessments will know which group the patient is in.
At the next visit, 3 months later, the patient will have a further assessment. If their stimulators have been "on" for the first 3 months, they will be switched off. If they have been "off" they will be switched on.
At the next visit, 3 months later, the patient will be assessed again and then given the opportunity to carry on the trial with the stimulators switched on for long term follow up.
- Conditions
- Tourette Syndrome
- Being tested
- Bilateral GPi Deep Brain Stimulation
- 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 GPi Deep Brain StimulationProcedure or surgery
Bilateral GPi Deep Brain Stimulation
| Study group | Role | What they receive |
|---|---|---|
| DBS Off first | Experimental | Not described Receives: Procedure: Bilateral GPi Deep Brain Stimulation |
| DBS On First | Experimental | Not described Receives: Procedure: Bilateral GPi Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale Global Tic Severity Scale
The Change in Scores on the Yale Global Tic Severity Scale will be compared between defined periods with stimulation switched ON v stimulation switched OFF.
Measured: Three months after stimulation switched ON v three months after stimulation switched OFF
Secondary outcomes (6)
Change in Modified Rush Video Rating scale
Measured: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Yale Brown Obsessive Compulsive Scale
Measured: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Neuropsychiatric Inventory
Measured: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Tourette Quality of life scale
Measured: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in MOVES scale
Measured: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Beck Depression Inventory
Measured: Three months after stimulation switched ON v three months after stimulation switched OFF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Foltynie, MBBS PhD, Principal investigator, UCL Institute of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647269
- Sponsor's protocol ID
- UCL 11/0226
- Status last verified
- Mar 2015
- First submitted
- 16 Jul 2012
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kefalopoulou Z, Zrinzo L, Jahanshahi M, Candelario J, Milabo C, Beigi M, Akram H, Hyam J, Clayton J, Kass-Iliyya L, Silverdale M, Evans J, Limousin P, Hariz M, Joyce E, Foltynie T. Bilateral globus pallidus stimulation for severe Tourette's syndrome: a double-blind, randomised crossover trial. Lancet Neurol. 2015 Jun;14(6):595-605. doi: 10.1016/S1474-4422(15)00008-3. Epub 2015 Apr 14.
PubMed 25882029
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Crossover Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Severe Tourette Syndrome
- ClinicalTrials.gov ID
- NCT01647269
- Acronym / sponsor ID
- UCL 11/0226
- Conditions
- Tourette Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Jul 2012 (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 investigate whether deep brain stimulation (DBS) of the globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS) and whether this treatment has any influence on social, psychological and behavioral disability and quality of life.
Detailed description
This study is aimed at adults who have severe Tourette syndrome and who have found that conventional treatments, such as drugs, do not control their symptoms sufficiently or cannot be tolerated.
The first two clinic visits will involve assessments. Participants will fill in a number of questionnaires and be examined by a psychiatrist and a neurologist. At the second visit, the patient will provide consent for participation and will undergo formal tests to find out if the participant is suitable and willing to undergo the research study and to record the type and severity of their Tourette syndrome symptoms.
The third visit will be an admission to hospital to have the deep brain stimulation (DBS) devices implanted. The admission to hospital should be around five days in duration.
At the first post operative follow-up visit, the patient will be placed into a "stimulator on" group or a "stimulator off" group. To try and make sure that these groups are the same to start with, each patient is put into a group by chance (randomly). This visit will take place around six weeks after surgery. In this trial, the participant will have an equal chance of being in the "on" or the "off" group first. This trial is also a "blinded" trial, neither the patient nor the researchers performing the assessments will know which group the patient is in.
At the next visit, 3 months later, the patient will have a further assessment. If their stimulators have been "on" for the first 3 months, they will be switched off. If they have been "off" they will be switched on.
At the next visit, 3 months later, the patient will be assessed again and then given the opportunity to carry on the trial with the stimulators switched on for long term follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS Off first | Experimental | Procedure: Bilateral GPi Deep Brain Stimulation |
| DBS On First | Experimental | Procedure: Bilateral GPi Deep Brain Stimulation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The participant must be adult with stable Tourette syndrome.
- The participant must have a chronic and severe tic disorder with severe functional impairment, with a Yale Tourette Severity Scale score of at least 35/55 for at least 12 months prior to surgery.
- The participant must have failed conventional medical treatment at therapeutic doses of three classes of medication.
- The participant must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful.
- The participant must have been on stable and optimised treatment of co-morbid conditions for at least 6 months.
Key exclusion criteria (9 listed)
- The tic disorder is attributable to any other condition.
- Any other medical or psychiatric disorders that substantially increase the risk of a failed procedure or that would significantly impede recovery.
- Psychosocial factors which might impede operative and post-operative care and research participation.
- Coagulation problems
- Other disease compromising life expectancy
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 GPi Deep Brain StimulationBilateral GPi Deep Brain Stimulation | Procedure or surgery | DBS Off first, DBS On First |
Primary outcome
Change in Yale Global Tic Severity Scale
Time frame: Three months after stimulation switched ON v three months after stimulation switched OFF
The Change in Scores on the Yale Global Tic Severity Scale will be compared between defined periods with stimulation switched ON v stimulation switched OFF.
6 secondary outcomes
Change in Modified Rush Video Rating scale
Time frame: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Yale Brown Obsessive Compulsive Scale
Time frame: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Neuropsychiatric Inventory
Time frame: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Tourette Quality of life scale
Time frame: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in MOVES scale
Time frame: Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Beck Depression Inventory
Time frame: Three months after stimulation switched ON v three months after stimulation switched OFF
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 19 Mar 2015.
- Derived from this study: PubMed 25882029Kefalopoulou Z, Zrinzo L, Jahanshahi M, Candelario J, Milabo C, Beigi M, Akram H, Hyam J, Clayton J, Kass-Iliyya L, Silverdale M, Evans J, Limousin P, Hariz M, Joyce E, Foltynie T. Bilateral globus pallidus stimulation for severe Tourette's syndrome: a double-blind, randomised crossover trial. Lancet Neurol. 2015 Jun;14(6):595-605. doi: 10.1016/S1474-4422(15)00008-3. Epub 2015 Apr 14.
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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.
Thomas Foltynie, MBBS PhD principal investigator
UCL Institute of Neurology
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 Bilateral GPi Deep Brain Stimulation in people with Tourette Syndrome, run by University College, London at 1 site in United Kingdom.
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 7 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 19 Mar 2015. 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 Kingdom. 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?
Change in Yale Global Tic Severity Scale (time frame: Three months after stimulation switched ON v three months after stimulation switched OFF). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647269, which also lists 1 linked publication.
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 19 Mar 2015.