Prefrontal Transcranial Random Noise Stimulation in Patients With Depression (tRNS-depr)

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

Study Overview

• Status: Terminated
• Conditions: Depression
• Intervention / Treatment: Device: Verum Prefrontal tRNS; Device: Placebo Prefrontal tRNS

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany, 93053
    • University of Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Regensburg
• Investigators: Principal Investigator: Berthold Langguth, University of Regensburg

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 14, 2016
• Study Completion (Actual): December 6, 2016

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: depression; trns
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: tRNS in depression

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No