eurocognitive Specification of Dysfunctions within Basal Ganglia-Cortex Loops and their Therapeutic Modulation by Deep Brain Stimulation in Patients with Obsessive Compulsive Disorders and Tourette Syndrome

Not Applicable

Recruiting

• Conditions: F95.2; F42; Combined vocal and multiple motor tic disorder [de la Tourette]; Obsessive-compulsive disorder

• Registration Number: DRKS00005316
• Lead Sponsor: niversitätsklinikum Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

For OCD and Tourette patients:
- chronic course
- serious expression with subjective distress and significant impairment of psychosocial functioning levels
- The patient agrees after detailed education about DBS and gives his written informed consent
- The patient agrees to a detailed evaluation

For OCD patients:
- OCD (ICD-10: F42) is the main psychiatric diagnosis
- strong symptom severity as measured by the YBOCS score
- At least one documented fully implemented cognitive-behavioral psychotherapy without sufficient success
- at least two unsuccessful drug therapies with SSRIs or clomipramine for 10 weeks in adequate doses
- At least one unsuccessful drug augmentation carried out for 10 weeks with one of the following medications: lithium, buspirone or neuroleptics

For Tourette patients:
- Tourette Syndrome (ICD-10: F95.2) is the main psychiatric diagnosis
- strong symptom severity as measured by the score YGTSS
- Inadequate symptom relief through drug treatment strategies, as a minimum pre-treatment with preparations from all three pharmacological groups listed (neuroleptics, benzodiazepines, alpha-agonists). This should be documented with adequate doses of at least 3-month treatment periods.

Exclusion Criteria

- Acute suicidality
- Simultaneously or previously existing schizophrenia according to DSM-IV criteria
- Abuse of or dependence on drugs or alcohol in the last six months
- Craniocerebral trauma in the anamnesis
- Clinically relevant internal or neurological diseases
- Pregnancy or breastfeeding
- Participation in a clinical trial within the last 30 days before the start of the study
- Intellectual deficit

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Obsessive compulsive symptoms should be measured 12 month after Operation using the YBOCS (Yale-Brown Obsessive Compulsive Scale).<br><br>Changes in Tic symptoms in Tourette patients should be measured 12 month after operation using the YGTSS (Yale Global Tic Severerity Scale).

Secondary Outcome Measures

Name	Time	Method
Psychopathology: STAI, HZI, IKP, SKID, GAF, DAPP-BQ, BDI, GAF, SCL-90<br>Neuropsychology: ToL, CPT, FWIT, Stroop-Test, Go/NoGo-Test, Inhibiton of Return, PPI<br>All examinations are executed preoperative as well as 6 and 12 month after operation