Schizophrenia
Conditions
Keywords
gesture, rTMS, cognitive remediation, social cognitive remediation therapy
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
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
Interventions
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
DEVICEplacebo 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
BEHAVIORALsocial 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
BEHAVIORALSham 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.
Sponsors
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Assessments will be conducted by blind assessors. Participants will be blind to the type of psychotherapy and the type of rTMS administered
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in gesture performance using the Test of Upper Limb Apraxia (TULIA) | 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
| Measure | Time frame | Description |
|---|---|---|
| change in Brief Negative Symptoms Scale (BNSS) | 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 |
| change in Self evaluation of negative symptoms (SNS) | 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 |
| change in Social and occupational functioning (SOFAS) | baseline, week 2, week 8, week 32 | rating scale on community functioning, total score is used ranging 0-100, higher scores indicated better functioning |
| change in the profile of nonverbal sensitivity (PONS) | 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 |
| change in functional capacity (UPSA brief) | 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 |
| change in neural activity during gesture planning using functional magnetic resonance imaging (fMRI) | 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 |
| number of participants with treatment related adverse events as assessed with rating scale | 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 |
| change in the specific level of functioning assessment scale (SLOF) | 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 |
Countries
Switzerland
Outcome results
None listed