Schizophrenia and Related Disorders Clinical Trial
— GesttDCSOfficial title:
Transcranial Direct Current Stimulation (tDCS) to Improve Gesture Control in Schizophrenia - a Randomised, Placebo-controlled, Double-blind Crossover Trial
Verified date | March 2024 |
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 10 min sessions of tDCS 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 tDCS session, which are separated by 24 hours. Results of this study will inform larger interventional trials comparing 2 tDCS protocols with repeated administration.
Status | Terminated |
Enrollment | 32 |
Est. completion date | March 22, 2024 |
Est. primary completion date | September 25, 2023 |
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 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) - Tattoos on head, neck or shoulder in close proximity to the electrode placement - Current skin problems on the scalp, eg. bruises or open wounds - History of neurosurgery, any severe head wounds, history of neurologic disorders impacting gesture, e.g. Parkinson's disease, stroke, multiple sclerosis - Active drug addiction except nicotine - Known contact allergies - 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 and group | 10 mins after tDCS intervention left IFG anodal | |
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 tDCS intervention left IFG cathodal | |
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 tDCS intervention left IPL anodal | |
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 tDCS intervention left IPL cathodal | |
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 tDCS intervention with placebo | |
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 mins 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 mins after tDCS intervention left IFG anodal | |
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 mins after tDCS intervention left IFG cathodal | |
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 mins after tDCS intervention left IPL anodal | |
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 mins after tDCS intervention left IPL cathodal | |
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 mins after tDCS intervention with placebo |
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