Multicentric double-blinded crossover randomized clinical trial of deep brain stimulation for intractable Tourette syndrome

Multicentric double-blinded crossover randomized clinical trial of deep brain stimulation for intractable Tourette syndrome - Crossover and randomization design of intractable Tourette syndrome after surgery (CARITAS) trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002849

Enrollment

Registered

2009-12-05

Start date

2010-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intractable Tourette syndrome

Interventions

A stereotactic operation is performed aided by functional software and computed tomography (CT) or magnetic resonance imaging (MRI). Two permanent quadripolar leads (model 3387, Medtronic) are implant

on&#39

or &#39

off&#39

is started in a double-blinded fashion 1 month more later. Group A: &#39

On&#39

for 3 months and &#39

for 3 months, then open-labeled &#39

for 6 months. Group B: &#39

Off&#39

for 6 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria are a diagnosis of TS as defined in the articles of the Tourette Syndrome Classification Study Group and in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revised (DSM-IV-TR), an age of 18 years or older, a Yale Global Tic Severity Scale17 (TGTSS) total tic severity score of 35/50 or more, an inadequate response to at least two dopamine receptor antagonists and other agents such as serotonergic drugs, antiepileptic drugs, and benzodiazepines, and inadequate response to any psychotherapy.

Exclusion criteria

Exclusion criteria: Exclusion criteria are a significant untreated structural brain lesion, a tic disorder due to other medical causes, no severe medical, neurological, psychiatric, or cognitive disorders that inordinately increase the risk (e.g., severe cardiovascular, pulmonary, or hematological disorders, epilepsy, a history of head injury, stroke, neurodegenerative disease, autism, schizophrenia, bipolar disorder, recent substance dependence, current pregnancy, and a recent history of suicide attempts).

Design outcomes

Primary

Measure	Time frame
Yale Global Tic Severity Scale (YGTSS) tic score	—

Secondary

Measure	Time frame
modified Rush Video-Based Rating Scale (mRVRS) YGTSS social impairment score Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score Short Form-36 (SF-36) Gilles de la Tourette syndrome-specific health-related -QOL scale (GTS-QOL)	—

Countries

Japan

Contacts

Public ContactTakanobu Kaido

National Center Hospital of Neurology and Psychiatry Department of Neurosurgery

kaido@ncnp.go.jp+81-42-341-2711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026