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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, week 2, week 8, week 32 |
| change in Brief Negative Symptoms Scale (BNSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Walther, MD | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bern, Translational Research Center, University Hospital of Psychiatry | Bern | 3000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35873264 | Derived | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D005868 | Gestures |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D007697 | Kinesics |
| D009633 | Nonverbal Communication |
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Assessments will be conducted by blind assessors. Participants will be blind to the type of psychotherapy and the type of rTMS administered
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| 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 |
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| 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. |
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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) | 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) | 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) | 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) | 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) | 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 | 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 |
| D003142 | Communication |
| D001519 | Behavior |