Schizophrenia and Related Disorders Clinical Trial
— GestTMSOfficial title:
Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Gesture Control in Schizophrenia: A Randomised, Placebo-controlled, Double-blind Crossover Trial
Verified date | April 2019 |
Source | University of Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The majority of schizophrenia patients is impaired in hand gesture performance, which contributes to poor functional outcome and poor communication skills. The left inferior frontal gyrus (IFG) and the left inferior parietal lobe (IPL) are key nodes of the gesture network, which is less active in patients with schizophrenia. Here, the investigators test single sessions of rTMS/TBS known to either enhance or inhibit local brain activity for app. 1 hour. The investigators aim to determine, which protocol may improve gesture performance in patients and healthy controls. This is a randomized, double-blind, cross-over, placebo-controlled single-center trial in 20 patients with schizophrenia spectrum disorders and 20 healthy controls. Gesture performance will be tested immediately after each TMS session, which are separated by 48 hours. Results of this study will inform larger interventional trials comparing 2 TMS protocols with repeated administration.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 23, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Right handed according to the Edinburgh Handedness Inventory - Ability and willingness to participate in the study - Ability to provide written informed consent - Informed Consent as documented by signature (Appendix Informed Consent Form) - Spent majority of childhood/adolescence in Switzerland - Patients: schizophrenia spectrum disorder according to Diagnostic and Statistical Manual version 5 (DSM-5) Exclusion Criteria: - Women who are pregnant or breast feeding - Metal objects on or in the body (e.g. grenade splinter, cardiac pacemaker, vessel clips, metal prostheses, contraceptive coil, cochlear implants, hearing aid, tooth implant) - History of neurosurgery, any severe head wounds, history of neurologic disorders impacting gesture, e.g. Parkinson's disease, stroke, multiple sclerosis sclerosis and epilepsy, convulsion or seizure - History of any hearing problems or ringing in the ears. - Active drug addiction except nicotine - Controls: first-degree relatives with schizophrenia spectrum disorders |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Psychiatry | Bern |
Lead Sponsor | Collaborator |
---|---|
University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test of Upper Limb Apraxia | Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group | 10 mins after baseline assessment | |
Primary | Test of Upper Limb Apraxia | Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment | 10 mins after left IFG iTBS | |
Primary | Test of Upper Limb Apraxia | Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment | 10 mins after right IPL cTBS | |
Primary | Test of Upper Limb Apraxia | Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment | 10 min after placebo stimulation | |
Secondary | Coin rotation | Test of dexterity, 3 trials of 10s to rotate a .5 Swiss Francs (SFr) coin between thumb, index and middle finger, video recorded, rated blindly according to number of coin half turns | 20 min after baseline assessment | |
Secondary | Coin rotation | Test of dexterity, 3 trials of 10s to rotate a .5 SFr coin between thumb, index and middle finger, video recorded, rated blindly according to number of coin half turns | 20 min after left IFG iTBS | |
Secondary | Coin rotation | Test of dexterity, 3 trials of 10s to rotate a .5 SFr coin between thumb, index and middle finger, video recorded, rated blindly according to number of coin half turns | 20 min after right IPL cTBS | |
Secondary | Coin rotation | Test of dexterity, 3 trials of 10s to rotate a .5 SFr coin between thumb, index and middle finger, video recorded, rated blindly according to number of coin half turns | 20 min after placebo stimulation |
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