An interventional study of left IFG anodal and left IFG cathodal in Schizophrenia and Related Disorders, sponsored by University of Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by University of Bern · Not applicable, 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 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.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 32 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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.
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.
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.
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
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
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
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
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
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
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
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
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
Single session of placebo tDCS over left IFG 10 min duration, 30 sec ramp during start and end
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 and group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 mins after tDCS intervention with placebo
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 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 20 mins after tDCS intervention with placebo
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.
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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