Contact information
Type
Scientific
Primary contact
Dr Hugh Rickards
ORCID ID
Contact details
Department of Neuropsychiatry
Queen Elizabeth Psychiatric Hospital
Edgbaston
Birmingham
B15 2QZ
United Kingdom
+44 (0)121 678 2019
hugh.rickards@bsmht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01647269
Protocol/serial number
V 1.0
Study information
Scientific title
Pilot randomised controlled trial of deep brain stimulation in Tourette syndrome
Acronym
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.
Ethics approval
Ethics approval applied for via:
1. COREC on 06/06/2007
2. NRES in December 2007
Study design
Randomised placebo-controlled crossover study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
Yale Global Tic severity scale.
Secondary outcome measures
1. Yale-Brown Obsessive Compulsive Scale
2. Hospital Anxiety and Depression Scale
3. Total Subjective Quality Of Life (TS-QOL)
Overall trial start date
01/04/2008
Overall trial end date
01/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adults with medically intractable Tourette syndrome for whom surgery and post-operative care is not contraindicated.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Tics for other neurological reasons
2. High risk for surgery or post-op care
Recruitment start date
01/04/2008
Recruitment end date
01/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Elizabeth Psychiatric Hospital
Birmingham
B15 2QZ
United Kingdom
Sponsor information
Organisation
University Hospital Birmingham NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
3rd Floor
Nuffield House
University Hospital
Edgbaston
Birmingham
B15
United Kingdom
+44 (0)121 4721311
chris.counsell@uhb.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Tourette Syndrome Association (UK) - applied for funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25882029