Not provided
Not provided
Not provided
Not provided
no efficacy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Transcranial random noise stimulation is used to stimulate the prefrontal cortices in patients with depression. It's a placebo-controlled two-arm study.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum Prefrontal tRNS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth | University of Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Regensburg | Regensburg | 93053 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo Prefrontal tRNS | Device | 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. |
|
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 | 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 | 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 | Change in alertness, working memory and divided attention over the course of the trial | day 3; day 19; day 75 |