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

Schizophrenia Clinical Trial

— BrAGG-SoS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106427
• Other study ID #: 2019-00798
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: April 24, 2024

Study information

• Verified date: May 2024
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 24, 2024
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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
• 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

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
• 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.

Locations

Country	Name	City	State
Switzerland	University of Bern, Translational Research Center, University Hospital of Psychiatry	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	baseline, week 2, week 8, week 32
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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