Pilot randomised controlled trial of deep brain stimulation in Tourette syndrome
| ISRCTN | ISRCTN45455499 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45455499 |
| ClinicalTrials.gov (NCT) | NCT01647269 |
| Protocol serial number | V 1.0 |
| Sponsor | University Hospital Birmingham NHS Foundation Trust (UK) |
| Funder | Tourette Syndrome Association (UK) - applied for funding |
- Submission date
- 02/07/2007
- Registration date
- 06/07/2007
- Last edited
- 27/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hugh Rickards
Scientific
Scientific
Department of Neuropsychiatry
Queen Elizabeth Psychiatric Hospital
Edgbaston
Birmingham
B15 2QZ
United Kingdom
| Phone | +44 (0)121 678 2019 |
|---|---|
| hugh.rickards@bsmht.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled crossover study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Pilot randomised controlled trial of deep brain stimulation in Tourette syndrome |
| Study objectives | Current hypothesis as of 05/12/2007: That bilateral deep brain stimulation applied to the globus pallidus internum will improve symptoms of Tourette syndrome, as measured by the Yale Global Tic Severity scale, when compared to sham stimulation. Previous hypothesis: That deep brain stimulation applied to the globus pallidus internum bilaterally will reduce tic scores significantly over one year compared to sham stimulation in Tourette syndrome. |
| Ethics approval(s) | Ethics approval applied for via: 1. COREC on 06/06/2007 2. NRES in December 2007 |
| Health condition(s) or problem(s) studied | Tourette syndrome |
| Intervention | Current interventions as of 05/12/2007: Group 1: Group 1 will have deep brain stimulation electrodes placed in the globus palludus internum. After 6 weeks, the electrodes will be switched on and adjusted maximally. After 3 months, electrodes will be switched off and the patient followed up after a further 3 months. Group 2: Group 2 will have deep brain stimulation electrodes placed in the globus pallidus internum. After 6 weeks, the participant will have a "sham" switching on of electrodes. After 3 months, the electrodes will be switched on and adjusted maximally. The patient will be followed up and assessed after a further 3 months. Previous interventions: Intervention group: Intervention group will have deep brain stimulation electrodes placed in globus pallidus externum. After 6 weeks, the electrodes will be switched on and further adjusted at 12 and 18 weeks. Follow-up assessments will then happen at 6 months, 9 months and 12 months. Control group: Control group will also have severe Tourette syndrome. They will also have electrodes implanted in the same way as the patients. After 6 weeks they will have a "sham switch on" proceedure. Follow-ups will be done in the same way as the intervention group. After one year of treatment, the code will be broken and data analysed. Participants in the intervention and control group will then be invited to participate in a further year of open-label extension study with all stimulators switched on. Data will then be gathered at 18 and 24 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Yale Global Tic severity scale. |
| Key secondary outcome measure(s) |
1. Yale-Brown Obsessive Compulsive Scale |
| Completion date | 01/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | Adults with medically intractable Tourette syndrome for whom surgery and post-operative care is not contraindicated. |
| Key exclusion criteria | 1. Tics for other neurological reasons 2. High risk for surgery or post-op care |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 01/04/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Queen Elizabeth Psychiatric Hospital
Birmingham
B15 2QZ
United Kingdom
B15 2QZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/06/2016: Publication reference added.
05/12/2007: this trial record was updated. The reason is that following a series of meetings about the protocol for this trial, the investigators have decided to change the methodology from parallel to crossover, mainly to increase the power of the study to detect any differences between treatment and placebo. Any changes to this record due to the above reason will be mentioned under the date 05/12/2007.
