- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03483909
Transcranial Magnetic Stimulation to Improve Gesture Control (GestTMS)
April 25, 2019 updated by: University of Bern
Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Gesture Control in Schizophrenia: A Randomised, Placebo-controlled, Double-blind Crossover Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bern, Switzerland, 3000
- University Hospital of Psychiatry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: left IFG iTBS
intermittent theta burst stimulation over the left inferior frontal gyrus
|
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
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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
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rTMS with a placebo coil that looks identical and makes identical noises for 180 s, localization over left IPL
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 mins after baseline assessment
|
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
|
10 mins after left IFG iTBS
|
Test of Upper Limb Apraxia
Time Frame: 10 mins after right IPL cTBS
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Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment
|
10 mins after right IPL cTBS
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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
|
10 min after placebo stimulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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20 min after baseline assessment
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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
|
20 min after left IFG iTBS
|
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
|
20 min after right IPL cTBS
|
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
|
20 min after placebo stimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2018
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
April 23, 2019
Study Registration Dates
First Submitted
March 25, 2018
First Submitted That Met QC Criteria
March 29, 2018
First Posted (Actual)
March 30, 2018
Study Record Updates
Last Update Posted (Actual)
April 29, 2019
Last Update Submitted That Met QC Criteria
April 25, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-02039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The investigators do not plan to share the data, because they cannot anonymize the video data sufficiently
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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