Prefrontal Transcranial Random Noise Stimulation in Patients With Depression

Depression Clinical Trial

— tRNS-depr  

Official title:

Prefrontal Transcranial Random Noise Stimulation in Patients With Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02207582
• Other study ID #: tRNS in depression
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 6, 2016

Study information

• Verified date: June 2018
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 6, 2016
• Est. primary completion date: October 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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 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.

Locations

Country	Name	City	State
Germany	University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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