Transcranial Magnetic Stimulation to Improve Gesture Control

NCT03483909 | Completed Phase 1 DMC

• 1 other identifier: 2017-02039
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of schizophrenia patients is impaired in hand gesture performance, which contributes to poor functional outcome and poor communication skills. The left inferior frontal gyrus (IFG) and the left inferior parietal lobe (IPL) are key nodes of the gesture network, which is less active in patients with schizophrenia. Here, the investigators test single sessions of rTMS/TBS known to either enhance or inhibit local brain activity for app. 1 hour. The investigators aim to determine, which protocol may improve gesture performance in patients and healthy controls. This is a randomized, double-blind, cross-over, placebo-controlled single-center trial in 20 patients with schizophrenia spectrum disorders and 20 healthy controls. Gesture performance will be tested immediately after each TMS session, which are separated by 48 hours. Results of this study will inform larger interventional trials comparing 2 TMS protocols with repeated administration.

Conditions

Schizophrenia and Related Disorders

Keywords

gesture; rTMS; nonverbal communication; schizophrenia; psychosis

Outcome Measures

Primary Outcomes (4)

• Test of Upper Limb Apraxia

  Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group

  10 mins after baseline assessment

• Test of Upper Limb Apraxia

  Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment

  10 mins after left IFG iTBS

• Test of Upper Limb Apraxia

  Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment

  10 mins after right IPL cTBS

• Test of Upper Limb Apraxia

  Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment

  10 min after placebo stimulation

Secondary Outcomes (4)

• Coin rotation

  20 min after baseline assessment

• Coin rotation

  20 min after left IFG iTBS

• Coin rotation

  20 min after right IPL cTBS

• Coin rotation

  20 min after placebo stimulation

Study Arms (3)

left IFG iTBS

EXPERIMENTAL

intermittent theta burst stimulation over the left inferior frontal gyrus

Device: left IFG iTBS

right IPL cTBS

ACTIVE COMPARATOR

continuous theta burst stimulation over the right inferior parietal cortex

Device: right IPL cTBS

placebo

PLACEBO COMPARATOR

Placebo TMS stimulation over the left inferior parietal cortex

Device: Placebo

Interventions

left IFG iTBS DEVICE

15 daily sessions of intermittent theta burst stimulation at 80% resting motor threshold, total duration of 190 s, localization using EEG 10/20 system at F3/F4

left IFG iTBS

right IPL cTBS DEVICE

15 daily sessions of continuous theta burst stimulation at 100% resting motor threshold, total duration of 45 s, localization using EEG 10/20 system at F3/F4

right IPL cTBS

Placebo DEVICE

rTMS with a placebo coil that looks identical and makes identical noises for 180 s, localization over left IPL

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right handed according to the Edinburgh Handedness Inventory
• Ability and willingness to participate in the study
• Ability to provide written informed consent
• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Spent majority of childhood/adolescence in Switzerland
• Patients: schizophrenia spectrum disorder according to Diagnostic and Statistical Manual version 5 (DSM-5)

You may not qualify if:

• Women who are pregnant or breast feeding
• Metal objects on or in the body (e.g. grenade splinter, cardiac pacemaker, vessel clips, metal prostheses, contraceptive coil, cochlear implants, hearing aid, tooth implant)
• History of neurosurgery, any severe head wounds, history of neurologic disorders impacting gesture, e.g. Parkinson's disease, stroke, multiple sclerosis sclerosis and epilepsy, convulsion or seizure
• History of any hearing problems or ringing in the ears.
• Active drug addiction except nicotine
• Controls: first-degree relatives with schizophrenia spectrum disorders

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University Hospital of Psychiatry

Bern, 3000, Switzerland

Location

MeSH Terms

Conditions

Schizophrenia; Gestures; Nonverbal Communication; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Kinesics; Communication; Behavior

Study Officials

• Sebastian Walther, MD

  University of Bern, University Hospital of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: participants, outcome assessors and raters are blinded. rTMS application is performed by an unblinded investigator
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, cross-over trial of 3 rTMS protocols

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: March 30, 2018
• Study Start: January 29, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 23, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)