A Phase 1/2 interventional study of left IFG iTBS and right IPL cTBS in Schizophrenia and Related Disorders, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-29.
Sponsored by University of Bern · Phase 1/2, Interventional, and Treatment
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.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 40 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
intermittent theta burst stimulation over the left inferior frontal gyrus
Device: left IFG iTBS
continuous theta burst stimulation over the right inferior parietal cortex
Device: right IPL cTBS
Placebo TMS stimulation over the left inferior parietal cortex
Device: Placebo
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
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
rTMS with a placebo coil that looks identical and makes identical noises for 180 s, localization over left IPL
Test of Upper Limb Apraxia
Standardized gesture performance test, video recorded and rated according to manual by a rater blind to treatment and group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 min after placebo stimulation
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 20 min after placebo stimulation
Plan to share: No — The investigators do not plan to share the data, because they cannot anonymize the video data sufficiently
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Apr 2019, 14 months.
Of 18 phase 1/2 interventional studies under Schizophrenia, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 70. This study's 14 months is below that.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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