Brain Stimulation And Group Therapy to Improve Gesture and Social Skills in Psychosis (BrAGG-SoS)

NCT04106427 | Completed

• 1 other identifier: 2019-00798
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Keywords

gesture; rTMS; cognitive remediation; social cognitive remediation therapy

Outcome Measures

Primary Outcomes (1)

• change in gesture performance using the Test of Upper Limb Apraxia (TULIA)

  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.

  baseline, week 2, week 8, week 32

Secondary Outcomes (8)

• change in the profile of nonverbal sensitivity (PONS)

  baseline, week 2, week 8, week 32

• change in Brief Negative Symptoms Scale (BNSS)

  baseline, week 2, week 8, week 32

• change in Self evaluation of negative symptoms (SNS)

  baseline, week 2, week 8, week 32

• change in Social and occupational functioning (SOFAS)

  baseline, week 2, week 8, week 32

• change in the specific level of functioning assessment scale (SLOF)

  baseline, week 2, week 8, week 32

Study Arms (3)

cTBS plus SCRT

EXPERIMENTAL

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

Device: continuous theta burst stimulation (cTBS); Behavioral: social cognitive remediation therapy (SCRT)

Placebo plus SCRT

PLACEBO COMPARATOR

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

Device: placebo cTBS; Behavioral: social cognitive remediation therapy (SCRT)

Sham SCRT

SHAM COMPARATOR

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

Behavioral: Sham group therapy

Interventions

continuous theta burst stimulation (cTBS) DEVICE

cTBS stimulation of 17 mins over right inferior parietal lobe (IPL) with two 44 s stimulations separated by 15 mins, 10 sessions in total (5 per week). intensity will be 100% of resting motor threshold at 30 Hz. administered in weeks 1 and 2 of the trial

cTBS plus SCRT

placebo cTBS DEVICE

Placebo stimulation of 17 mins over right IPL with two 44 s stimulations separated by 15 mins, 10 sessions in total (5 per week). intensity will be 0% of resting motor threshold at 30 Hz. administered in weeks 1 and 2 of the trial

Placebo plus SCRT

social cognitive remediation therapy (SCRT) BEHAVIORAL

16 sessions of group SCRT will be scheduled within 8 weeks, comprising 6-8 participants per group with 2 therapists. Duration of group sessions will be 60-90 mins. The content will follow the manual of SCRT and we will add a short intervention to practice the use of co-speech gestures at each session

Placebo plus SCRT; cTBS plus SCRT

Sham group therapy BEHAVIORAL

Group activities in closed groups of 6 participants. Schedule of two sessions per week for 8 weeks. Two therapists are guiding different leisure activities, e.g. group walks, going to museums/movies, games.

Sham SCRT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern, Translational Research Center, University Hospital of Psychiatry

Bern, 3000, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35873264 DERIVED

MeSH Terms

Conditions

Schizophrenia; Gestures

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Kinesics; Nonverbal Communication; Communication; Behavior

Study Officials

• Sebastian Walther, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessments will be conducted by blind assessors. Participants will be blind to the type of psychotherapy and the type of rTMS administered
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 27, 2019
• Study Start: December 1, 2019
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)