Prefrontal Transcranial Random Noise Stimulation in Patients With Depression

Not Applicable

Terminated

• Conditions: Depression
• Interventions: Device: Verum Prefrontal tRNS; Device: Placebo Prefrontal tRNS

• Registration Number: NCT02207582
• Lead Sponsor: University of Regensburg

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-04
• Primary Completion: 2016-10-14
• Study Completion: 2016-12-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum Prefrontal tRNS	Verum Prefrontal tRNS	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 Prefrontal tRNS	Placebo Prefrontal tRNS	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.

Primary Outcome Measures

Name	Time	Method
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	Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Regensburg; 🇩🇪 Regensburg, Germany