- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03463902
Transcranial Direct Current Stimulation (tDCS) to Improve Gesture Control (GesttDCS)
Transcranial Direct Current Stimulation (tDCS) to Improve Gesture Control in Schizophrenia - a Randomised, Placebo-controlled, Double-blind Crossover Trial
Study Overview
Status
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. Transcranial direct current stimulation (tDCS) for 10 mins is a very safe method to alter brain states locally for a period of 1-2 hours. Indeed, facilitatory stimulation of the left frontal cortex by tDCS demonstrated improved gesture perception and interpretation in healthy subjects. Furthermore, patients with apraxia identified gestures better after facilitatory tDCS over the left inferior parietal lobe (IPL). Thus, the investigators hypothesize that local changes of brain activity within the gesture network would change gesture performance.Particularly, anodal (facilitatory) stimulation of the left IFG would improve gesture performance. The investigators will test single sessions of tDCS 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 10 min session of anodal tDCS over the left IFG on gesture performance compared to three active and one placebo tDCS 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 10 min tDCS protocol each day, immediately followed by assessments of gesture performance and dexterity. Gesture performance will be measured with video recorded Test of Upper Limb Apraxia, which is rated blindly according to a manual. Active comparisons are cathodal tDCS over left IFG, anodal tDCS over left IPL and cathodal tDCS over left IPL.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bern, Switzerland, 3000
- University Hospital of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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 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)
- Tattoos on head, neck or shoulder in close proximity to the electrode placement
- Current skin problems on the scalp, eg. bruises or open wounds
- History of neurosurgery, any severe head wounds, history of neurologic disorders impacting gesture, e.g. Parkinson's disease, stroke, multiple sclerosis
- Active drug addiction except nicotine
- Known contact allergies
- Controls: first-degree relatives with schizophrenia spectrum disorders
Study Plan
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 anodal
2 mA Stimulation of 10 min, anodal electrode over left IFG, cathodal electrode over right IFG, 30 sec ramp to start and 30 sec ramp to stop
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Single session of transcranial direct current stimulation (tDCS) over left IFG anodal stimulation 2 mA Stimulation of 10 min, anodal electrode over left IFG, cathodal electrode over right IFG, 30 sec ramp to start and 30 sec ramp to stop |
Active Comparator: left IFG cathodal
2 mA Stimulation of 10 min, cathodal electrode over left IFG, anodal electrode over right IFG, 30 sec ramp to start and 30 sec ramp to stop
|
Single session of transcranial direct current stimulation (tDCS) over left IFG cathodal stimulation 2 mA Stimulation of 10 min, cathodal electrode over left IFG, anodal electrode over right IFG, 30 sec ramp to start and 30 sec ramp to stop |
Active Comparator: left IPL anodal
2 mA Stimulation of 10 min, anodal electrode over left IPL, cathodal electrode over right IPL, 30 sec ramp to start and 30 sec ramp to stop
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Single session of transcranial direct current stimulation (tDCS) over left IPL anodal stimulation 2 mA Stimulation of 10 min, anodal electrode over left IPL, cathodal electrode over right IPL, 30 sec ramp to start and 30 sec ramp to stop
|
Active Comparator: left IPL cathodal
2 mA Stimulation of 10 min, anodal electrode over left IFG, cathodal electrode over right IFG, 30 sec ramp to start and 30 sec ramp to stop
|
Single session of transcranial direct current stimulation (tDCS) over left IPL cathodal stimulation 2 mA Stimulation of 10 min, anodal electrode over left IFG, cathodal electrode over right IFG, 30 sec ramp to start and 30 sec ramp to stop
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Placebo Comparator: Placebo
anodal electrode over left IFG, cathodal electrode over right IFG, stimulation only during 30 sec ramp at beginning and end of 10 min
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Single session of placebo tDCS over left IFG 10 min duration, 30 sec ramp during start and end
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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
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Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
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10 mins after baseline assessment
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Test of Upper Limb Apraxia
Time Frame: 10 mins after tDCS intervention left IFG anodal
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Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
|
10 mins after tDCS intervention left IFG anodal
|
Test of Upper Limb Apraxia
Time Frame: 10 mins after tDCS intervention left IFG cathodal
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Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
|
10 mins after tDCS intervention left IFG cathodal
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Test of Upper Limb Apraxia
Time Frame: 10 mins after tDCS intervention left IPL anodal
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Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
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10 mins after tDCS intervention left IPL anodal
|
Test of Upper Limb Apraxia
Time Frame: 10 mins after tDCS intervention left IPL cathodal
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Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
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10 mins after tDCS intervention left IPL cathodal
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Test of Upper Limb Apraxia
Time Frame: 10 mins after tDCS intervention with placebo
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Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
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10 mins after tDCS intervention with placebo
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coin Rotation
Time Frame: 20 mins after baseline assessment
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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
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20 mins after baseline assessment
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Coin Rotation
Time Frame: 20 mins after tDCS intervention left IFG anodal
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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
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20 mins after tDCS intervention left IFG anodal
|
Coin Rotation
Time Frame: 20 mins after tDCS intervention left IFG cathodal
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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 mins after tDCS intervention left IFG cathodal
|
Coin Rotation
Time Frame: 20 mins after tDCS intervention left IPL anodal
|
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 mins after tDCS intervention left IPL anodal
|
Coin Rotation
Time Frame: 20 mins after tDCS intervention left IPL cathodal
|
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 mins after tDCS intervention left IPL cathodal
|
Coin Rotation
Time Frame: 20 mins after tDCS intervention with placebo
|
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 mins after tDCS intervention with placebo
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sebastian Walther, MD, University of Bern, University Hospital of Psychiatry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-01995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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