Condition category
Mental and Behavioural Disorders
Date applied
02/07/2007
Date assigned
06/07/2007
Last edited
27/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www2.uhb.nhs.uk/Homepage.aspx

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25882029

Publication citations

Additional files

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.