Clinical trial NCT04106427: Brain Stimulation And Group Therapy to Improve Gesture and Social Skills in Psychosis (BrAGG-SoS)
Official title: Brain Stimulation And Group Therapy to Improve Gesture and Social Skills in Psychosis (BrAGG-SoS) - a Randomized, Placebo-controlled, Double-blind Trial of Transcranial Magnetic Stimulation and Group Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: gesture
rTMS
cognitive remediation
social cognitive remediation therapy
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 therapy on gesture performance and nonverbal communication skills in schizophrenia

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 performance and thus nonverbal communication in schizophrenia

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: change in gesture performance using the Test of Upper Limb Apraxia (TULIA)
timeFrame: baseline, week 2, week 8, week 32
Secondary outcomes:
measure: change in the profile of nonverbal sensitivity (PONS)
timeFrame: baseline, week 2, week 8, week 32
measure: change in Brief Negative Symptoms Scale (BNSS)
timeFrame: baseline, week 2, week 8, week 32
measure: change in Self evaluation of negative symptoms (SNS)
timeFrame: baseline, week 2, week 8, week 32
measure: change in Social and occupational functioning (SOFAS)
timeFrame: baseline, week 2, week 8, week 32
measure: change in the specific level of functioning assessment scale (SLOF)
timeFrame: baseline, week 2, week 8, week 32
measure: change in functional capacity (UPSA brief)
timeFrame: baseline, week 2, week 8, week 32
measure: change in neural activity during gesture planning using functional magnetic resonance imaging (fMRI)
timeFrame: baseline, week 8
measure: number of participants with treatment related adverse events as assessed with rating scale
timeFrame: week 2
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern, Translational Research Center, University Hospital of Psychiatry
Study officials:
affiliation: University of Bern
name: Sebastian Walther, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chapellier V, Pavlidou A, Mueller DR, Walther S. Brain Stimulation and Group Therapy to Improve Gesture and Social Skills in Schizophrenia-The Study Protocol of a Randomized, Sham-Controlled, Three-Arm, Double-Blind Trial. Front Psychiatry. 2022 Jul 7;13:909703. doi: 10.3389/fpsyt.2022.909703. eCollection 2022.