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

Primary Purpose

Depression

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Verum Prefrontal tRNS
Placebo Prefrontal tRNS
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression; trns

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Regensburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum Prefrontal tRNS

Placebo Prefrontal tRNS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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))

Secondary Outcome Measures

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
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)
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
Change in the Beck Depression Inventory over the course of the trial
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
Change in alertness, working memory and divided attention over the course of the trial

Full Information

First Posted
July 31, 2014
Last Updated
June 14, 2018
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT02207582
Brief Title
Prefrontal Transcranial Random Noise Stimulation in Patients With Depression
Acronym
tRNS-depr
Official Title
Prefrontal Transcranial Random Noise Stimulation in Patients With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
no efficacy
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 14, 2016 (Actual)
Study Completion Date
December 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression; trns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum Prefrontal tRNS
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Prefrontal tRNS
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Verum Prefrontal tRNS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo Prefrontal tRNS
Intervention Description
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 Measure Information:
Title
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))
Description
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
Secondary Outcome Measure Information:
Title
Change in depression severity measured by the Major Depression Inventory over the course of the trial
Description
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
Title
Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment)
Description
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
Title
Change in the Clinical Global Impression Scale over the course of the trial
Description
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
Title
Change in the Beck Depression Inventory over the course of the trial
Description
Change in the Beck Depression Inventory over the course of the trial
Time Frame
day 3; day 5; day 12; day 19; day 75
Title
Change in alertness, working memory and divided attention over the course of the trial
Description
Change in alertness, working memory and divided attention over the course of the trial
Time Frame
day 3; day 19; day 75

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Prefrontal Transcranial Random Noise Stimulation in Patients With Depression

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