Prefrontal Transcranial Random Noise Stimulation in Patients With Depression

Study Overview
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Brief Summary
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Transcranial random noise stimulation is used to stimulate the prefrontal cortices in patients with depression. It's a placebo-controlled two-arm study.

Detailed Description
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Transcranial random noise stimulation (tRNS) is a non-invasive electric stimulation technique of the brain which was shown to be superior effective in contrast to other electric stimulation such as transcranial direct current stimulation (tDCS). These studies investigated mainly healthy controls and specific tasks. Only one case report is available for depression. Here we stimulate patients with depression with tRNS in a placebo-controlled two-arm design. Stimulation will be done as add-on to standard therapy. Electrodes will be applied over both dorsolateral prefrontal cortices which are standard target points of tDCS and also transcranial magnetic stimulation in depression.

Official Title
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Prefrontal Transcranial Random Noise Stimulation in Patients With Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Verum Prefrontal tRNS
* Device: Placebo Prefrontal tRNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: episode of depression (unipolar or bipolar) ( ICD-10) female or male between 18 and 70 years old skills to participate in all study procedures 18 or more points in the Hamilton rating scale or depression written informed consent Exclusion Criteria: clinically relevant unstable internal or neurological comorbidity evidence of significant brain malformations or neoplasm, head injury cerebral vascular events neurodegenerative disorders affecting the brain or prior brain surgery metal objects in and around body that can not be removed pregnancy alcohol or drug abuse eczema on the head heart pacemaker high dose tranquillizers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum Prefrontal tRNS<br>2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. | Device: Verum Prefrontal tRNS<br>* 2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.<br>|
| Placebo Comparator: Placebo Prefrontal tRNS<br>2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation. | Device: Placebo Prefrontal tRNS<br>* 2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19)) | Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19)) | day 3; day 19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression severity measured by the Major Depression Inventory over the course of the trial | Change in depression severity measured by the Major Depression Inventory over the course of the trial | day 10; -day 3; day 5; day 12; day 19; day 75 | 
| Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment) | Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment) | day 3; day 19 | 
| Change in the Clinical Global Impression Scale over the course of the trial | Change in the Clinical Global Impression Scale over the course of the trial | day 3; day 5; day 12; day 19; day 75 | 
| Change in the Beck Depression Inventory over the course of the trial | Change in the Beck Depression Inventory over the course of the trial | day 3; day 5; day 12; day 19; day 75 | 
| Change in alertness, working memory and divided attention over the course of the trial | Change in alertness, working memory and divided attention over the course of the trial | day 3; day 19; day 75 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression; trns