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

University of Regensburg (UR)

Status: Terminated

Conditions: Depression

Treatments: Device: Verum Prefrontal tRNS; Device: Placebo Prefrontal tRNS

Study type: Interventional

Funder types: Other

Identifiers

NCT02207582

tRNS in depression

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

44 participants in 2 patient groups, including a placebo group

Verum Prefrontal tRNS

Experimental group

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.

Treatment:

Device: Verum Prefrontal tRNS

Placebo Prefrontal tRNS

Placebo Comparator group

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.

Treatment:

Device: Placebo Prefrontal tRNS