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SchizophreniaBrAGG-SoSNCT04106427

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

A study testing continuous theta burst stimulation (cTBS) and social cognitive remediation therapy (SCRT) in people with Schizophrenia, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia
What is being tested?
continuous theta burst stimulation (cTBS) and social cognitive remediation therapy (SCRT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
73 participants
Where
1 siteSwitzerland
Study dates
1 Dec 2019to 24 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Bern, 3000

Other trials in Switzerland

About this study

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

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

Read the 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

Conditions
Schizophrenia
Being tested
continuous theta burst stimulation (cTBS), placebo cTBS, social cognitive remediation therapy (SCRT), Sham group therapy
Keywords
gesture, rTMS, cognitive remediation, social cognitive remediation therapy
Medical subject headings
Schizophrenia, Gestures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 cTBSDevice

    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)Behavioural

    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 therapyBehavioural

    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.

Study groups in NCT04106427
Study groupRoleWhat they receive
cTBS plus SCRTExperimental10 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
Receives: Device: continuous theta burst stimulation (cTBS); Behavioral: social cognitive remediation therapy (SCRT)
Placebo plus SCRTPlacebo comparator10 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
Receives: Device: placebo cTBS; Behavioral: social cognitive remediation therapy (SCRT)
Sham SCRTSham comparator16 sessions of sham social cognitive remediation therapy (SCRT) twice per week over an eight week period. Participants will engage in non-effective group activities
Receives: Behavioral: Sham group therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, week 2, week 8, week 32

Secondary outcomes (8)

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

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

    Measured: baseline, week 2, week 8, week 32

  2. change in Brief Negative Symptoms Scale (BNSS)

    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

    Measured: baseline, week 2, week 8, week 32

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

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

    Measured: baseline, week 2, week 8, week 32

  4. change in Social and occupational functioning (SOFAS)

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

    Measured: baseline, week 2, week 8, week 32

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

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

    Measured: baseline, week 2, week 8, week 32

  6. change in functional capacity (UPSA brief)

    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

    Measured: baseline, week 2, week 8, week 32

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

    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

    Measured: baseline, week 8

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

    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

    Measured: week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2019
  2. Study start1 Dec 2019
  3. Primary completion24 Apr 2024
  4. Study completion24 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04106427
Sponsor's protocol ID
2019-00798
Other IDs
2019
Acronym
BrAGG-SoS
Status last verified
Aug 2025
First submitted
17 Sep 2019
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35873264

Questions about this trial

What is this clinical trial studying?

A study testing continuous theta burst stimulation (cTBS) and social cognitive remediation therapy (SCRT) in people with Schizophrenia, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in gesture performance using the Test of Upper Limb Apraxia (TULIA) (time frame: baseline, week 2, week 8, week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04106427, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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