NCT01647269

Brief Summary

The purpose of this study is to investigate whether deep brain stimulation (DBS) of the globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS) and whether this treatment has any influence on social, psychological and behavioral disability and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

3.3 years

First QC Date

July 16, 2012

Last Update Submit

March 18, 2015

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in Yale Global Tic Severity Scale

    The Change in Scores on the Yale Global Tic Severity Scale will be compared between defined periods with stimulation switched ON v stimulation switched OFF.

    Three months after stimulation switched ON v three months after stimulation switched OFF

Secondary Outcomes (6)

  • Change in Modified Rush Video Rating scale

    Three months after stimulation switched ON v three months after stimulation switched OFF

  • Change in Yale Brown Obsessive Compulsive Scale

    Three months after stimulation switched ON v three months after stimulation switched OFF

  • Change in Neuropsychiatric Inventory

    Three months after stimulation switched ON v three months after stimulation switched OFF

  • Change in Tourette Quality of life scale

    Three months after stimulation switched ON v three months after stimulation switched OFF

  • Change in MOVES scale

    Three months after stimulation switched ON v three months after stimulation switched OFF

  • +1 more secondary outcomes

Study Arms (2)

DBS Off first

EXPERIMENTAL
Procedure: Bilateral GPi Deep Brain Stimulation

DBS On First

EXPERIMENTAL
Procedure: Bilateral GPi Deep Brain Stimulation

Interventions

Bilateral GPi Deep Brain StimulationPROCEDURE

Bilateral GPi Deep Brain Stimulation

DBS Off firstDBS On First

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The participant must be adult with stable Tourette syndrome.
  • The participant must have a chronic and severe tic disorder with severe functional impairment, with a Yale Tourette Severity Scale score of at least 35/55 for at least 12 months prior to surgery.
  • The participant must have failed conventional medical treatment at therapeutic doses of three classes of medication.
  • The participant must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful.
  • The participant must have been on stable and optimised treatment of co-morbid conditions for at least 6 months.
  • The participant must be actively involved with and compliant with any psychosocial interventions.
  • The patient must be compliant with treatment plans.

You may not qualify if:

  • The tic disorder is attributable to any other condition.
  • Any other medical or psychiatric disorders that substantially increase the risk of a failed procedure or that would significantly impede recovery.
  • Psychosocial factors which might impede operative and post-operative care and research participation.
  • Coagulation problems
  • Other disease compromising life expectancy
  • Patient likely to benefit from psychological intervention
  • Patient unwilling to co-operate with post operative assessment and care
  • Pregnancy.
  • Participant under 20 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL Institute of Neurology

London, United Kingdom

Location

Related Publications (1)

  • Kefalopoulou Z, Zrinzo L, Jahanshahi M, Candelario J, Milabo C, Beigi M, Akram H, Hyam J, Clayton J, Kass-Iliyya L, Silverdale M, Evans J, Limousin P, Hariz M, Joyce E, Foltynie T. Bilateral globus pallidus stimulation for severe Tourette's syndrome: a double-blind, randomised crossover trial. Lancet Neurol. 2015 Jun;14(6):595-605. doi: 10.1016/S1474-4422(15)00008-3. Epub 2015 Apr 14.

    PMID: 25882029DERIVED

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Thomas Foltynie, MBBS PhD

    UCL Institute of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 23, 2012

Study Start

July 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

GB(1)