Schizophrenia Clinical Trial
Official title:
Efficacy and Mechanisms of Transcranial Direct Current Stimulation (tDCS) - Effects on Working Memory in Schizophrenia
NCT number | NCT02823639 |
Other study ID # | 01EE1407H |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | October 2022 |
Impairments of cognition are a core, severely disabling feature of schizophrenia leading to poor long-term outcome with no established treatment available. Particularly impaired executive functions (e.g working memory) are frequently observed and are consistently associated with reduced activation of the dorsolateral prefrontal cortex (dlPFC). Deficits in those functions have been shown to be closely related to negative symptoms, thought disorder, and functional outcome in schizophrenia leading to the notion that frontal lobe dysfunction is crucially important in schizophrenic psychopathology. Noninvasive brain stimulation like tDCS can enhance executive functions like working memory in healthy subjects as well as in patients. To identify the optimal parameters for this intervention in patients with schizophrenia, the investigators first test the effects of different polarities (anodal, cathodal), stimulation intensities (1mA, 2mA) and laterality (left, right) on working-memory performance (nback task) in a sham-controlled cross-over design (n=128). To elucidate mechanisms of action, oscillatory brain activity will be registered with electroencephalography (EEG). These experiments will provide reliable data for an evidence-based development of new clinical interventions to improve treatment of cognitive deficits in patients with schizophrenia and thus enhance schizophrenia prevention and recovery.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | October 2022 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - diagnosed schizophrenia (DSM-V) - age (18 - 60 years) - right handedness - stable medication during 1 week of treatment and 1 week before Exclusion Criteria: - history of seizures - metal device throughout the body - pregnancy - use of anticonvulsive medication - use of benzodiazepines more than 1 mg of Lorazepam equivalent - current substance abuse (nicotine excluded) |
Country | Name | City | State |
---|---|---|---|
Germany | LMU Muenchen, Department of Psychiatry and Psychotherapy | Muenchen | |
Germany | University Hospital Tuebigen, Department of Psychiatry and Psychotherapy | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | University Hospital Munich |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of dprime | dprime provides the separation between the means of the signal and the noise distributions, compared against the standard deviation of the signal plus noise distributions | Assessment during stimulation in a n-back task at three specific timepoints during one week | |
Secondary | Change of reaction time in n-back task | Assessment during stimulation in a n-back task at three specific timepoints during one week |
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