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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
continuous theta burst stimulation (cTBS)
placebo cTBS
social cognitive remediation therapy (SCRT)
Sham group therapy
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring gesture, rTMS, cognitive remediation, social cognitive remediation therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Sham Comparator

Arm Label

cTBS plus SCRT

Placebo plus SCRT

Sham SCRT

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
change in Social and occupational functioning (SOFAS)
rating scale on community functioning, total score is used ranging 0-100, higher scores indicated better functioning
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
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
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
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

Full Information

First Posted
September 17, 2019
Last Updated
February 13, 2023
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04106427
Brief Title
Brain Stimulation And Group Therapy to Improve Gesture and Social Skills in Psychosis (BrAGG-SoS)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bern

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
gesture, rTMS, cognitive remediation, social cognitive remediation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cTBS plus SCRT
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo plus SCRT
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Sham SCRT
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
continuous theta burst stimulation (cTBS)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
placebo cTBS
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
social cognitive remediation therapy (SCRT)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Sham group therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in gesture performance using the Test of Upper Limb Apraxia (TULIA)
Description
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.
Time Frame
baseline, week 2, week 8, week 32
Secondary Outcome Measure Information:
Title
change in the profile of nonverbal sensitivity (PONS)
Description
profile of nonverbal sensitivity (PONS), short test of the interpretation of video clips, total score will be evaluated, higher scores indicate better performance
Time Frame
baseline, week 2, week 8, week 32
Title
change in Brief Negative Symptoms Scale (BNSS)
Description
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
Time Frame
baseline, week 2, week 8, week 32
Title
change in Self evaluation of negative symptoms (SNS)
Description
questionnaire on subjective negative symptoms, includes 20 items. total scores will be used ranging 0-40 with higher scores indicating increased symptom severity
Time Frame
baseline, week 2, week 8, week 32
Title
change in Social and occupational functioning (SOFAS)
Description
rating scale on community functioning, total score is used ranging 0-100, higher scores indicated better functioning
Time Frame
baseline, week 2, week 8, week 32
Title
change in the specific level of functioning assessment scale (SLOF)
Description
rating scale on community functioning, total scores are used ranging 43-215 with higher scores indicating better functioning
Time Frame
baseline, week 2, week 8, week 32
Title
change in functional capacity (UPSA brief)
Description
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
Time Frame
baseline, week 2, week 8, week 32
Title
change in neural activity during gesture planning using functional magnetic resonance imaging (fMRI)
Description
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
Time Frame
baseline, week 8
Title
number of participants with treatment related adverse events as assessed with rating scale
Description
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
Time Frame
week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anastasia Pavlidou, PhD
Phone
+41 0(31) 9308707
Email
anastasia.pavlidou@upd.unibe.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Chapellier
Email
victoria.chapellier@upd.unibe.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Walther, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bern, Translational Research Center, University Hospital of Psychiatry
City
Bern
ZIP/Postal Code
3000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasia Pavlidou, PhD
Email
anastasia.pavlidou@upd.unibe.ch
First Name & Middle Initial & Last Name & Degree
Victoria Chapellier
Email
victoria.chapellier@upd.unibe.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35873264
Citation
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.
Results Reference
derived

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

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