Prefrontal Transcranial Random Noise Stimulation in Patients With Depression

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 14, 2016

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.

Interventions

  • Device: 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.
  • Device: 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.

Arms, Groups and Cohorts

  • Experimental: 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 Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

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

  • Change in depression severity measured by the Major Depression Inventory over the course of the trial
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: day 3; day 5; day 12; day 19; day 75
    • Change in the Clinical Global Impression Scale over the course of the trial
  • Change in the Beck Depression Inventory over the course of the trial
    • Time Frame: 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
    • Time Frame: day 3; day 19; day 75
    • Change in alertness, working memory and divided attention over the course of the trial

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Regensburg
  • Provider of Information About this Clinical Study
    • Principal Investigator: Berthold Langguth, MD, Ph.D., MD, PhD – University of Regensburg
  • Overall Official(s)
    • Berthold Langguth, Principal Investigator, University of Regensburg

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.