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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bern
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- change in gesture performance using the Test of Upper Limb Apraxia (TULIA)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Assessments will be conducted by blind assessors. Participants will be blind to the type of psychotherapy and the type of rTMS administered
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
cTBS plus SCRT
10 daily sessions of continous theta burst (cTBS) on the right inferior parietal cortex for two weeks together with 16 sessions of social cognitive remediation therapy (SCRT) twice per week over an eight week period according to the manual
Intervention: continuous theta burst stimulation (cTBS) (Device)
cTBS plus SCRT
10 daily sessions of continous theta burst (cTBS) on the right inferior parietal cortex for two weeks together with 16 sessions of social cognitive remediation therapy (SCRT) twice per week over an eight week period according to the manual
Intervention: social cognitive remediation therapy (SCRT) (Behavioral)
Placebo plus SCRT
10 daily sessions of placebo continous theta burst (cTBS) on the right inferior parietal cortex for two weeks together with 16 sessions of social cognitive remediation therapy (SCRT) twice per week over an eight week period according to the manual
Intervention: placebo cTBS (Device)
Placebo plus SCRT
10 daily sessions of placebo continous theta burst (cTBS) on the right inferior parietal cortex for two weeks together with 16 sessions of social cognitive remediation therapy (SCRT) twice per week over an eight week period according to the manual
Intervention: social cognitive remediation therapy (SCRT) (Behavioral)
Sham SCRT
16 sessions of sham social cognitive remediation therapy (SCRT) twice per week over an eight week period. Participants will engage in non-effective group activities
Intervention: Sham group therapy (Behavioral)
Outcomes
Primary Outcomes
change in gesture performance using the Test of Upper Limb Apraxia (TULIA)
Time Frame: baseline, week 2, week 8, week 32
Test of upper limb apraxia (TULIA), recorded on video and scored according to manual. contains 48 items (gestures performed on verbal or visual instruction), total score ranges 0-240; higher scores indicate better performance.
Secondary Outcomes
- change in Social and occupational functioning (SOFAS)(baseline, week 2, week 8, week 32)
- change in Self evaluation of negative symptoms (SNS)(baseline, week 2, week 8, week 32)
- number of participants with treatment related adverse events as assessed with rating scale(week 2)
- change in the profile of nonverbal sensitivity (PONS)(baseline, week 2, week 8, week 32)
- change in functional capacity (UPSA brief)(baseline, week 2, week 8, week 32)
- change in neural activity during gesture planning using functional magnetic resonance imaging (fMRI)(baseline, week 8)
- change in Brief Negative Symptoms Scale (BNSS)(baseline, week 2, week 8, week 32)
- change in the specific level of functioning assessment scale (SLOF)(baseline, week 2, week 8, week 32)