Transcranial Direct Current Stimulation (tDCS) to Improve Gesture Control

NCT03463902 | Terminated DMC

• 1 other identifier: 2017-01995
• Study Type: interventional
• Target: 32
• 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 10 min sessions of tDCS 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 tDCS session, which are separated by 24 hours. Results of this study will inform larger interventional trials comparing 2 tDCS protocols with repeated administration.

Conditions

Schizophrenia and Related Disorders

Keywords

Gesture; tDCS; schizophrenia; nonverbal communication

Outcome Measures

Primary Outcomes (6)

• 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 and group

  10 mins after tDCS intervention left IFG anodal

• 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 tDCS intervention left IFG cathodal

• 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 tDCS intervention left IPL anodal

• 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 tDCS intervention left IPL cathodal

• 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 tDCS intervention with placebo

Secondary Outcomes (6)

• Coin Rotation

  20 mins after baseline assessment

• Coin Rotation

  20 mins after tDCS intervention left IFG anodal

• Coin Rotation

  20 mins after tDCS intervention left IFG cathodal

• Coin Rotation

  20 mins after tDCS intervention left IPL anodal

• Coin Rotation

  20 mins after tDCS intervention left IPL cathodal

Study Arms (5)

left IFG anodal

EXPERIMENTAL

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

Device: left IFG anodal

left IFG cathodal

ACTIVE COMPARATOR

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

Device: left IFG cathodal

left IPL anodal

ACTIVE COMPARATOR

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

Device: left IPL anodal

left IPL cathodal

ACTIVE COMPARATOR

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

Device: left IPL cathodal

Placebo

PLACEBO COMPARATOR

anodal electrode over left IFG, cathodal electrode over right IFG, stimulation only during 30 sec ramp at beginning and end of 10 min

Device: Placebo

Interventions

left IFG anodal DEVICE

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

left IFG anodal

left IFG cathodal DEVICE

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

left IFG cathodal

left IPL anodal DEVICE

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

left IPL anodal

left IPL cathodal DEVICE

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

left IPL cathodal

Placebo DEVICE

Single session of placebo tDCS over left IFG 10 min duration, 30 sec ramp during start and end

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 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)
• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University Hospital of Psychiatry

Bern, 3000, Switzerland

Location

MeSH Terms

Conditions

Schizophrenia; Gestures; Nonverbal Communication

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: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: participants, outcome assessors and raters are blinded. tDCS 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 5 tDCS protocols

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 13, 2018
• Study Start: January 29, 2018
• Primary Completion: September 25, 2023
• Study Completion: March 22, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)