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

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ClinicalTrials.gov Identifier: NCT02207582
Recruitment Status : Terminated (no efficacy)
First Posted : August 4, 2014
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., 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.

Condition or disease Intervention/treatment Phase
Depression Device: Verum Prefrontal tRNS Device: Placebo Prefrontal tRNS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prefrontal Transcranial Random Noise Stimulation in Patients With Depression
Study Start Date : July 2014
Actual Primary Completion Date : October 14, 2016
Actual Study Completion Date : December 6, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207582


Locations
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Germany
University of Regensburg
Regensburg, Germany, 93053
Sponsors and Collaborators
University of Regensburg
Investigators
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Principal Investigator: Berthold Langguth University of Regensburg

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Responsible Party: Berthold Langguth, MD, Ph.D., MD, PhD, University of Regensburg
ClinicalTrials.gov Identifier: NCT02207582     History of Changes
Other Study ID Numbers: tRNS in depression
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Berthold Langguth, MD, Ph.D., University of Regensburg:
depression; trns
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders