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

March 26, 2024 updated by: Sebastian Walther, MD, University of Bern

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3000
        • University of Bern, Translational Research Center, University Hospital of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: continuous theta burst stimulation (cTBS)

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

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

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
Sham Comparator: 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
Behavioral: Sham group therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, week 2, week 8, week 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, week 2, week 8, week 32
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
baseline, week 2, week 8, week 32
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
baseline, week 2, week 8, week 32
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
baseline, week 2, week 8, week 32
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
baseline, week 2, week 8, week 32
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
baseline, week 2, week 8, week 32
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
baseline, week 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
week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Principal Investigator: Sebastian Walther, MD, University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-00798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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