Schizophrenia and Related DisordersPhase 1/2GestTMSNCT03483909
Transcranial Magnetic Stimulation to Improve Gesture Control
A Phase 1/2 study testing left IFG iTBS and right IPL cTBS 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 iTBS and right IPL cTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jan 2018to 23 Apr 2019
- Phase
- Phase 1/2
- 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 Diagnostic and Statistical Manual version 5 (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)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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. 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.
- Conditions
- Schizophrenia and Related Disorders
- Being tested
- left IFG iTBS, right IPL cTBS, Placebo
- Keywords
- gesture, rTMS, nonverbal communication, schizophrenia, psychosis
- Medical subject headings
- Schizophrenia, Gestures, Nonverbal Communication, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left IFG iTBSDevice
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
right IPL cTBSDevice
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
PlaceboDevice
rTMS with a placebo coil that looks identical and makes identical noises for 180 s, localization over left IPL
| Study group | Role | What they receive |
|---|---|---|
| left IFG iTBS | Experimental | intermittent theta burst stimulation over the left inferior frontal gyrus Receives: Device: left IFG iTBS |
| right IPL cTBS | Active comparator | continuous theta burst stimulation over the right inferior parietal cortex Receives: Device: right IPL cTBS |
| placebo | Placebo comparator | Placebo TMS stimulation over the left inferior parietal cortex 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
Measured: 10 mins after left IFG iTBS
Test of Upper Limb Apraxia
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment
Measured: 10 mins after right IPL cTBS
Test of Upper Limb Apraxia
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment
Measured: 10 min after placebo stimulation
Secondary outcomes (4)
Coin rotation
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
Measured: 20 min 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 min after left IFG iTBS
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 min after right IPL cTBS
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 min after placebo stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start29 Jan 2018
- Primary completion1 Apr 2019
- Study completion23 Apr 2019
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, double-blind, cross-over trial of 3 rTMS protocols
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 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
- NCT03483909
- Sponsor's protocol ID
- 2017-02039
- Other IDs
- 2017
- Acronym
- GestTMS
- Status last verified
- Apr 2019
- First submitted
- 25 Mar 2018
- Last updated
- 29 Apr 2019
- 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 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Gesture Control in Schizophrenia: A Randomised, Placebo-controlled, Double-blind Crossover Trial
- ClinicalTrials.gov ID
- NCT03483909
- Acronym / sponsor ID
- GestTMS / 2017-02039
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- gesture, rTMS, nonverbal communication, schizophrenia, psychosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 30 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, double-blind, cross-over trial of 3 rTMS protocols
| Arm | Type | Receives |
|---|---|---|
| left IFG iTBS | Experimental | Device: left IFG iTBSintermittent theta burst stimulation over the left inferior frontal gyrus |
| right IPL cTBS | Active comparator | Device: right IPL cTBScontinuous theta burst stimulation over the right inferior parietal cortex |
| placebo | Placebo comparator | Device: PlaceboPlacebo TMS stimulation over the left inferior parietal cortex |
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 (6 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)
- 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
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 iTBS15 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 | Device | left IFG iTBS |
| right IPL cTBS15 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 | Device | right IPL cTBS |
| PlaceborTMS with a placebo coil that looks identical and makes identical noises for 180 s, localization over left IPL | 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 left IFG iTBS
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment
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
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
4 secondary outcomes
Coin rotation
Time frame: 20 min after baseline assessment
Coin rotation
Time frame: 20 min after left IFG iTBS
Coin rotation
Time frame: 20 min after right IPL cTBS
Coin rotation
Time frame: 20 min after placebo stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- 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 Phase 1/2 study testing left IFG iTBS and right IPL cTBS 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 6 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: finished, as of the sponsor's last update on 29 Apr 2019. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 4 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 29 Apr 2019.