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Completed

NCT Number: NCT04106427

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bern, 3000, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

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.

Primary outcomes

  1. 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

  1. change in the profile of nonverbal sensitivity (PONS)

    Time frame: baseline, week 2, week 8, week 32

    profile of nonverbal sensitivity (PONS), short test of the interpretation of video clips, total score will be evaluated, higher scores indicate better performance

  2. change in Brief Negative Symptoms Scale (BNSS)

    Time frame: baseline, week 2, week 8, week 32

    rating instrument to assess severity of negative symptoms with 13 items, total score will be used ranging 0-78, higher scores indicate higher symptom severity

  3. change in Self evaluation of negative symptoms (SNS)

    Time frame: baseline, week 2, week 8, week 32

    questionnaire on subjective negative symptoms, includes 20 items. total scores will be used ranging 0-40 with higher scores indicating increased symptom severity

  4. change in Social and occupational functioning (SOFAS)

    Time frame: baseline, week 2, week 8, week 32

    rating scale on community functioning, total score is used ranging 0-100, higher scores indicated better functioning

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

    Time frame: baseline, week 2, week 8, week 32

    rating scale on community functioning, total scores are used ranging 43-215 with higher scores indicating better functioning

  6. change in functional capacity (UPSA brief)

    Time frame: baseline, week 2, week 8, week 32

    brief version of the University of California in San Diego Performance-based Skills Assessment (UPSA-brief), short assessment of skills, total scores are used ranging from 0-100 with higher scores indicating better skill performance

  7. change in neural activity during gesture planning using functional magnetic resonance imaging (fMRI)

    Time frame: baseline, week 8

    pantomime task during functional magnetic resonance imaging. Blood oxygenation level depended (BOLD) signal change from baseline to week 8 will be compared during gesture planning within the cerebral praxis network. Standard fMRI analyses procedures will be applied

  8. number of participants with treatment related adverse events as assessed with rating scale

    Time frame: week 2

    after each repetitive transcranial magnetic stimulation (rTMS) session participants will be inquired about adverse events. after 5 sessions and after 10 sessions, a structured questionnaire will be applied following the guidelines for rTMS treatment. This will assess specific adverse events and their severity

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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

Acronym: BrAGG-SoS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2019
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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