Status:
COMPLETED
Brain Stimulation And Group Therapy to Improve Gesture and Social Skills in Psychosis (BrAGG-SoS)
Lead Sponsor:
University of Bern
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Randomized, double-blind, placebo-controlled clinical trial testing the effects of 10 sessions of continuous theta burst stimulation and the effects of 16 sessions of social cognitive remediation ther...
Detailed Description
The study focuses on nonverbal communication skills in schizophrenia. The trial will test, whether the combination of noninvasive brain stimulation and group psychotherapy will improve gesture perform...
Eligibility Criteria
Inclusion
- Right-handed subjects
- Ability and willingness to participate in the study
- Ability to provide written informed consent
- Informed Consent as documented by signature
- schizophrenia spectrum disorders according to Diagnostic and statistical manual version 5 (DSM-5)
Exclusion
- Substance abuse or dependence other than nicotine
- Past or current medical or neurological condition associated with impaired or aberrant movement, such as brain tumors, stroke, M. Parkinson, M. Huntington, dystonia, or severe head trauma with subsequent loss of consciousness.
- Epilepsy or other convulsions
- History of any hearing problems or ringing in the ears
- Standard exclusion criteria for cerebral magnetic resonance imaging scanning and transcranial magnetic stimulation (TMS); e.g. metal implants, claustrophobia
- Patients only: any transcranial magnetic stimulation (TMS) treatment in the past 3 months
- Patients only: any cognitive remediation therapy in the past 2 years
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
- Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2024
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04106427
Start Date
December 1 2019
End Date
April 24 2024
Last Update
August 8 2025
Active Locations (1)
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1
University of Bern, Translational Research Center, University Hospital of Psychiatry
Bern, Switzerland, 3000