Clinical trial NCT02207582: Prefrontal Transcranial Random Noise Stimulation in Patients With Depression
Official title: Prefrontal Transcranial Random Noise Stimulation in Patients With Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: depression; trns
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))
timeFrame: day 3; day 19
Secondary outcomes:
measure: Change in depression severity measured by the Major Depression Inventory over the course of the trial
timeFrame: day 10; -day 3; day 5; day 12; day 19; day 75
measure: Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment)
timeFrame: day 3; day 19
measure: Change in the Clinical Global Impression Scale over the course of the trial
timeFrame: day 3; day 5; day 12; day 19; day 75
measure: Change in the Beck Depression Inventory over the course of the trial
timeFrame: day 3; day 5; day 12; day 19; day 75
measure: Change in alertness, working memory and divided attention over the course of the trial
timeFrame: day 3; day 19; day 75
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth
role: PRINCIPAL_INVESTIGATOR
References: