Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT01647269
Eligibility Criteria:
Inclusion Criteria:
1. The participant must be adult with stable Tourette syndrome.
2. 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.
3. The participant must have failed conventional medical treatment at therapeutic doses of three classes of medication.
4. The participant must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful.
5. The participant must have been on stable and optimised treatment of co-morbid conditions for at least 6 months.
6. The participant must be actively involved with and compliant with any psychosocial interventions.
7. The patient must be compliant with treatment plans.
Exclusion Criteria:
1. The tic disorder is attributable to any other condition.
2. Any other medical or psychiatric disorders that substantially increase the risk of a failed procedure or that would significantly impede recovery.
3. Psychosocial factors which might impede operative and post-operative care and research participation.
4. Coagulation problems
5. Other disease compromising life expectancy
6. Patient likely to benefit from psychological intervention
7. Patient unwilling to co-operate with post operative assessment and care
8. Pregnancy.
9. Participant under 20 years old.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01647269
Study Brief:
Protocol Section:
NCT01647269