Pilot randomised controlled trial of deep brain stimulation in Tourette syndrome

ISRCTN ISRCTN45455499
DOI https://doi.org/10.1186/ISRCTN45455499
ClinicalTrials.gov number NCT01647269
Secondary identifying numbers V 1.0
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

Department of Neuropsychiatry
Queen Elizabeth Psychiatric Hospital
Edgbaston
Birmingham
B15 2QZ
United Kingdom

Phone +44 (0)121 678 2019
Email hugh.rickards@bsmht.nhs.uk

Study information

Study designRandomised placebo-controlled crossover study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePilot randomised controlled trial of deep brain stimulation in Tourette syndrome
Study objectivesCurrent 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) studiedTourette syndrome
InterventionCurrent 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 typeProcedure/Surgery
Primary outcome measureYale Global Tic severity scale.
Secondary outcome measures1. Yale-Brown Obsessive Compulsive Scale
2. Hospital Anxiety and Depression Scale
3. Total Subjective Quality Of Life (TS-QOL)
Overall study start date01/04/2008
Completion date01/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteriaAdults with medically intractable Tourette syndrome for whom surgery and post-operative care is not contraindicated.
Key exclusion criteria1. Tics for other neurological reasons
2. High risk for surgery or post-op care
Date of first enrolment01/04/2008
Date of final enrolment01/04/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queen Elizabeth Psychiatric Hospital
Birmingham
B15 2QZ
United Kingdom

Sponsor information

University Hospital Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Department
3rd Floor
Nuffield House, University Hospital
Edgbaston
Birmingham
B15
United Kingdom

Phone +44 (0)121 4721311
Email chris.counsell@uhb.nhs.uk
Website http://www2.uhb.nhs.uk/Homepage.aspx
ROR logo "ROR" https://ror.org/014ja3n03

Funders

Funder type

Charity

Tourette Syndrome Association (UK) - applied for funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

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.