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Transcranial Magnetic Stimulation to Improve Gesture Control (GestTMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483909
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
University of Bern

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.

Condition or disease Intervention/treatment Phase
Schizophrenia and Related Disorders Device: left IFG iTBS Device: right IPL cTBS Device: Placebo Phase 1 Phase 2

Detailed Description:
Schizophrenia is associated with poor social functioning, which is perturbed by deficits in social interaction including nonverbal communication. The use of hand gestures is critical for nonverbal communication, but the majority of schizophrenia patients has severe gesture impairments. Today no intervention may ameliorate gesture impairments. Patients with gesture impairments have altered structure and function of the gesture network, particularly the left inferior frontal gyrus (IFG) and also the left inferior parietal lobe (IPL). Noninvasive brain stimulation techniques may alter local brain function. Repetitive transcranial magnetic stimulation (rTMS) and particularly theta burst stimulation (TBS) for a few mins is a very safe method to alter brain states locally for approximately 1 hour. Indeed, facilitatory stimulation of the left frontal cortex by transcranial direct current stimulation (tDCS) demonstrated improved gesture perception and interpretation in healthy subjects. In addition, inhibitory stimulation with continuous theta burst stimulation (cTBS) over left IFG may perturb gesture performance in healthy subjects. Thus, the investigators hypothesize that local changes of brain activity within the gesture network would change gesture performance. Particularly, facilitatory intermittent theta burst stimulation (iTBS) of the left IFG would improve gesture performance. The investigators will test single sessions of rTMS in healthy subjects and schizophrenia patients. If one of the protocols proves to have superior effects, this result will help to plan interventional trials targeting social interaction deficits in schizophrenia. The aim of the study is to determine the effect of one session of iTBS over the left IFG on gesture performance compared to cTBS over the right IPL (active comparator) and one placebo rTMS sessions. This is a randomized, double-blind, cross-over, placebo-controlled single-center trial in 20 patients with schizophrenia spectrum disorders and 20 healthy controls. After baseline assessment of gesture performance, participants will receive one rTMS protocol at each time point, immediately followed by assessments of gesture performance and dexterity. rTMS sessions will be separated by 48 hours. Gesture performance will be measured with video recorded Test of Upper Limb Apraxia, which is rated blindly according to a manual.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, double-blind, cross-over trial of 3 rTMS protocols
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: participants, outcome assessors and raters are blinded. rTMS application is performed by an unblinded investigator
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Gesture Control in Schizophrenia: A Randomised, Placebo-controlled, Double-blind Crossover Trial
Actual Study Start Date : January 29, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: left IFG iTBS
intermittent theta burst stimulation over the left inferior frontal gyrus
Device: left IFG iTBS
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

Active Comparator: right IPL cTBS
continuous theta burst stimulation over the right inferior parietal cortex
Device: right IPL cTBS
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

Placebo Comparator: placebo
Placebo TMS stimulation over the left inferior parietal cortex
Device: Placebo
rTMS with a placebo coil that looks identical and makes identical noises for 180 s, localization over left IPL




Primary Outcome Measures :
  1. Test of Upper Limb Apraxia [ Time Frame: 10 mins after baseline assessment ]
    Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group

  2. Test of Upper Limb Apraxia [ Time Frame: 10 mins after left IFG iTBS ]
    Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment

  3. Test of Upper Limb Apraxia [ Time Frame: 10 mins after right IPL cTBS ]
    Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment

  4. Test of Upper Limb Apraxia [ Time Frame: 10 min after placebo stimulation ]
    Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment


Secondary Outcome Measures :
  1. Coin rotation [ Time Frame: 20 min after baseline assessment ]
    Test of dexterity, 3 trials of 10s to rotate a .5 Swiss Francs (SFr) coin between thumb, index and middle finger, video recorded, rated blindly according to number of coin half turns

  2. Coin rotation [ Time Frame: 20 min after left IFG iTBS ]
    Test of dexterity, 3 trials of 10s to rotate a .5 SFr coin between thumb, index and middle finger, video recorded, rated blindly according to number of coin half turns

  3. Coin rotation [ Time Frame: 20 min after right IPL cTBS ]
    Test of dexterity, 3 trials of 10s to rotate a .5 SFr coin between thumb, index and middle finger, video recorded, rated blindly according to number of coin half turns

  4. Coin rotation [ Time Frame: 20 min after placebo stimulation ]
    Test of dexterity, 3 trials of 10s to rotate a .5 SFr coin between thumb, index and middle finger, video recorded, rated blindly according to number of coin half turns



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483909


Locations
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Switzerland
University Hospital of Psychiatry
Bern, Switzerland, 3000
Sponsors and Collaborators
University of Bern
Investigators
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Principal Investigator: Sebastian Walther, MD University of Bern, University Hospital of Psychiatry

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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03483909    
Other Study ID Numbers: 2017-02039
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan to share the data, because they cannot anonymize the video data sufficiently

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Bern:
gesture
rTMS
nonverbal communication
schizophrenia
psychosis
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders