Schizophrenia and Related DisordersGesttDCSNCT03463902
Transcranial Direct Current Stimulation (tDCS) to Improve Gesture Control
A study testing left IFG anodal, left IFG cathodal and left IPL anodal in people with Schizophrenia and Related Disorders, run by University of Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Related Disorders
- What is being tested?
- left IFG anodal, left IFG cathodal and left IPL anodal
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jan 2018to 22 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) 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 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.
Read the 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.
- Conditions
- Schizophrenia and Related Disorders
- Being tested
- left IFG anodal, left IFG cathodal, left IPL anodal, left IPL cathodal, Placebo
- Keywords
- Gesture, tDCS, schizophrenia, nonverbal communication
- Medical subject headings
- Schizophrenia, Gestures, Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left IFG anodalDevice
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 cathodalDevice
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 IPL anodalDevice
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 cathodalDevice
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
PlaceboDevice
Single session of placebo tDCS over left IFG 10 min duration, 30 sec ramp during start and end
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Upper Limb Apraxia
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 mins after tDCS intervention with placebo
Secondary outcomes (6)
Coin Rotation
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
Measured: 20 mins after baseline assessment
Coin Rotation
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
Measured: 20 mins after tDCS intervention left IFG anodal
Coin Rotation
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
Measured: 20 mins after tDCS intervention left IFG cathodal
Coin Rotation
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
Measured: 20 mins after tDCS intervention left IPL anodal
Coin Rotation
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
Measured: 20 mins after tDCS intervention left IPL cathodal
Coin Rotation
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
Measured: 20 mins after tDCS intervention with placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start29 Jan 2018
- Primary completion25 Sep 2023
- Study completion22 Mar 2024
Why it stopped: Recruitment failed to enroll sufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, double-blind, cross-over trial of 5 tDCS protocols
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Walther, MD, Principal investigator, University of Bern, University Hospital of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463902
- Sponsor's protocol ID
- 2017-01995
- Other IDs
- 2017
- Acronym
- GesttDCS
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2018
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share the data, because they cannot anonymize the video data sufficiently
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) to Improve Gesture Control in Schizophrenia - a Randomised, Placebo-controlled, Double-blind Crossover Trial
- ClinicalTrials.gov ID
- NCT03463902
- Acronym / sponsor ID
- GesttDCS / 2017-01995
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- Gesture, tDCS, schizophrenia, nonverbal communication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment failed to enroll sufficient number of patients
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
- Model description
- randomized, double-blind, cross-over trial of 5 tDCS protocols
| Arm | Type | Receives |
|---|---|---|
| left IFG anodal | Experimental | Device: left IFG anodal2 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 cathodal | Active comparator | Device: left IFG cathodal2 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 IPL anodal | Active comparator | Device: left IPL anodal2 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 cathodal | Active comparator | Device: left IPL cathodal2 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 |
| Placebo | Placebo comparator | Device: Placeboanodal electrode over left IFG, cathodal electrode over right IFG, stimulation only during 30 sec ramp at beginning and end of 10 min |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| left IFG anodalSingle 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 | Device | left IFG anodal |
| left IFG cathodalSingle 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 | Device | left IFG cathodal |
| left IPL anodalSingle 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 | Device | left IPL anodal |
| left IPL cathodalSingle 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 | Device | left IPL cathodal |
| PlaceboSingle session of placebo tDCS over left IFG 10 min duration, 30 sec ramp during start and end | Device | Placebo |
Primary outcome
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
Test of Upper Limb Apraxia
Time frame: 10 mins after tDCS intervention left IFG anodal
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
Test of Upper Limb Apraxia
Time frame: 10 mins after tDCS intervention left IFG cathodal
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
Test of Upper Limb Apraxia
Time frame: 10 mins after tDCS intervention left IPL anodal
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
Test of Upper Limb Apraxia
Time frame: 10 mins after tDCS intervention left IPL cathodal
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
Test of Upper Limb Apraxia
Time frame: 10 mins after tDCS intervention with placebo
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
6 secondary outcomes
Coin Rotation
Time frame: 20 mins after baseline assessment
Coin Rotation
Time frame: 20 mins after tDCS intervention left IFG anodal
Coin Rotation
Time frame: 20 mins after tDCS intervention left IFG cathodal
Coin Rotation
Time frame: 20 mins after tDCS intervention left IPL anodal
Coin Rotation
Time frame: 20 mins after tDCS intervention left IPL cathodal
Coin Rotation
Time frame: 20 mins after tDCS intervention with placebo
Results and safety
The study was stopped early (reason given: Recruitment failed to enroll sufficient number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No. The investigators do not plan to share the data, because they cannot anonymize the video data sufficiently
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Walther, MD principal investigator
University of Bern, University Hospital of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left IFG anodal, left IFG cathodal and left IPL anodal in people with Schizophrenia and Related Disorders, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment failed to enroll sufficient number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Upper Limb Apraxia (time frame: 10 mins after baseline assessment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.