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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial direct-current stimulation | Experimental | 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) |
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| Sham tDCS | Sham Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct-current stimulation (tDCS) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction on the severity of auditory verbal hallucinations | Reduction of Auditory Hallucinations Rating Scale (AHRS (12) items) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of tDCS on other schizophrenia symptoms | Reduction of scores in Positive and Negative Symptom Scale | 8 weeks |
| Impact of tDCS on Clinical Global Impression | Global Severity of Illness measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Lindenmayer, MD | Manhattan Psychiatric Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Psychiatric Center | New York | New York | 10035 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19348793 | Result | Nitsche MA, Boggio PS, Fregni F, Pascual-Leone A. Treatment of depression with transcranial direct current stimulation (tDCS): a review. Exp Neurol. 2009 Sep;219(1):14-9. doi: 10.1016/j.expneurol.2009.03.038. Epub 2009 Apr 5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 2, 2020 | |
| Reset | Oct 27, 2020 | |
| Release | Nov 13, 2020 | |
| Reset | Dec 10, 2020 | |
| Release | Mar 15, 2021 | |
| Reset | Apr 7, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 2, 2020 | Oct 27, 2020 | |||
| Nov 13, 2020 |
| ID | Term |
|---|---|
| D006212 | Hallucinations |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Two group randomized, parallel design
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Raters were blind as was PI.
|
|
| Placebo | Device | 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 |
|
|
| 8 weeks |
| Impact of tDCS on MATRICS | MATRICS: Comprehensive assessment of cognitive functions | 8 weeks |
| Dec 10, 2020 |
| Mar 15, 2021 | Apr 7, 2021 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |