NCT02207582

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2016

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

2.3 years

First QC Date

July 31, 2014

Last Update Submit

June 14, 2018

Conditions

Depression

Keywords

depression; trns

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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)

    day 3; day 19

  • 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

    day 3; day 5; day 12; day 19; day 75

  • Change in alertness, working memory and divided attention over the course of the trial

    day 3; day 19; day 75

Study Arms (2)

Verum Prefrontal tRNS

EXPERIMENTAL

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

Placebo Prefrontal tRNS

PLACEBO COMPARATOR

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

Interventions

Verum Prefrontal tRNSDEVICE

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.

Verum Prefrontal tRNS
Placebo Prefrontal tRNSDEVICE

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.

Placebo Prefrontal tRNS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • episode of depression (unipolar or bipolar) ( ICD-10)
  • female or male between 18 and 70 years old
  • skills to participate in all study procedures
  • or more points in the Hamilton rating scale or depression
  • written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regensburg

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Berthold Langguth

    University of Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 4, 2014

Study Start

July 1, 2014

Primary Completion

October 14, 2016

Study Completion

December 6, 2016

Last Updated

June 18, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)