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19 November 2008
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| [ Print-friendly version ] |
| Pilot randomised controlled trial of deep brain stimulation in Tourette syndrome |
| ISRCTN | ISRCTN45455499 |
| ClinicalTrials.gov identifier | |
| Public title | Pilot randomised controlled trial of deep brain stimulation in Tourette syndrome |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | V 1.0 |
| Study hypothesis |
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. Please note that as of 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. |
| Ethics approval |
Ethics approval applied for via:
1. COREC on 6th June 2007 2. NRES in December 2007 |
| Study design | Randomised, placebo controlled crossover study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Tourette syndrome |
| Participants - inclusion criteria | Adults with medically intractable Tourette syndrome for whom surgery and post-operative care is not contraindicated. |
| Participants - exclusion criteria |
1. Tics for other neurological reasons
2. High risk for surgery or post-op care |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 01/04/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 20 |
| Interventions |
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. |
| Primary outcome measure(s) | Yale Global Tic severity scale. |
| Secondary outcome measure(s) |
1. Yale-Brown Obsessive Compulsive Scale
2. Hospital Anxiety and Depression Scale 3. Total Subjective Quality Of Life (TS-QOL) |
| Sources of funding | Tourette Syndrome Association (UK) - applied for funding |
| Trial website | |
| Publications | |
| Contact name | Dr Hugh Rickards |
| Address |
Department of Neuropsychiatry
Queen Elizabeth Psychiatric Hospital Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2QZ |
| Country | United Kingdom |
| Tel | +44 (0)121 678 2019 |
| Fax | +44 (0)121 6782079 |
| hugh.rickards@bsmht.nhs.uk | |
| Sponsor | University Hospital Birmingham NHS Foundation Trust (UK) |
| Address |
Research and Development Department
3rd Floor Nuffield House, University Hospital Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 |
| Country | United Kingdom |
| Tel | +44 (0)121 4721311 |
| chris.counsell@uhb.nhs.uk | |
| Sponsor website: | http://www2.uhb.nhs.uk/Homepage.aspx |
| Date applied | 02/07/2007 |
| Last edited | 11/09/2008 |
| Date ISRCTN assigned | 06/07/2007 |
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