An interventional study of Transcranial direct-current stimulation (tDCS) and Placebo in Auditory Hallucination and Schizophrenia, sponsored by Manhattan Psychiatric Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by Manhattan Psychiatric Center · Not applicable, Interventional, and Treatment
This is a 4 week therapeutic pilot study with a 4 week follow-up period involving inpatients with treatment resistant DSM-IV schizophrenia or schizoaffective disorder diagnosis. Each eligible subject will receive either 20 minutes of active tDCS (transcranial direct-current stimulation) or sham stimulation twice a day on 5 consecutive weekdays for 4 weeks with a 4 week follow-up period.
The aim in this study is to conduct a pilot study on the efficacy of tDCS by assessing its efficacy in treatment refractory auditory verbal hallucinations in inpatients with chronic schizophrenia. Based on and expanding the findings by Brunelin et al. the hypothesis is that tDCS treatment with the cathode on the left temporal-parietal junction and the anode on the left dorsolateral prefrontal cortex can reduce the severity of auditory verbal hallucinations in patients with treatment refractory schizophrenia. The impact of tDCS on other schizophrenia symptoms in secondary exploratory outcome analyses together with the examination of the durability of an ameliorating effect will also be investigated.
136 studies on the registry are indexed under Hallucinations; 35 are open to participants now.
This study's enrollment of 27 is below the median of 48 across 118 interventional studies indexed under Hallucinations.
Browse Hallucinations studies →Manhattan Psychiatric Center is the lead sponsor of 9 studies on the registry; 1 is 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.
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.
Intervention of 2 mAmp Transcranial direct-current stimulation treatments given twice daily for 20 min each per day for 4 weeks on consecutive weekdays. Twice-daily sessions were separated by at least 3 hours (one in the AM and the other one in the PM)
Device: Transcranial direct-current stimulation (tDCS)
Intervention of placebo stimulation with ranscranial direct-current stimulation(sham tDCS), the stimulation parameters were displayed, but after 40 seconds of real stimulation of 2 mAmp to simulate the tDCS induced skin sensation, only a small current pulse was delivered every 550 msec (110 mAmp over 15 msec) through the remainder of the 20-minute period
Device: Placebo
Stimulation sessions will be conducted twice a day on 5 consecutive weekdays. The twice daily sessions will be separated by at least 3 hours (one in the morning and the other one in the PM). The duration of treatment will be 4 weeks
Also known as: Active Transcranial direct-current stimulation (tDCS)'
Placebo/sham stimulation: After 40 seconds of real stimulation of 2 mAmp to simulate the tDCS induced skin sensation, only a small current pulse is delivered every 550 msec (110 mAmp over 15 msec) through the remainder of the 20-minute period
Also known as: Sham Transcranial direct-current stimulation (tDCS)
Reduction on the severity of auditory verbal hallucinations
Reduction of Auditory Hallucinations Rating Scale (AHRS (12) items)
Time frame: 8 weeks
Impact of tDCS on other schizophrenia symptoms
Reduction of scores in Positive and Negative Symptom Scale
Time frame: 8 weeks
Impact of tDCS on Clinical Global Impression
Global Severity of Illness measure
Time frame: 8 weeks
Impact of tDCS on MATRICS
MATRICS: Comprehensive assessment of cognitive functions
Time frame: 8 weeks
Plan to share: No
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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