NCT02846740

Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients.

Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This pilot study aims to investigate whether a treatment called cranial electric stimulation or CES can decrease risk factors for suicide. The specific CES device we will use is called Alpha-Stim®. CES will be used in addition to usual treatment (medication and group therapy).

Detailed description

Suicide is still a major issue in the United States and all around the world. There are many reasons for people attempting suicide and the major modifiable risk factors are depression, anxiety, insomnia, and agitation. The standard treatment for all suicidal patients includes medication, admission to a hospital and reducing the risk factors. Medications have potential side effects and concerns about the drug interactions. One of the biological treatment alternatives to medication is cranial electric stimulation. This technique uses a device to stimulate the brain through electrical current. Using an Alpha-Stim® device, current is applied to the brain using skin electrodes which can be easily clipped on to the earlobe. The amount of current used is very low and is 1/1000 th of the current used for electroconvulsive therapy (ECT) and 1/10 th to 1/20 th of the 1-2 milliamperes used with transcranial direct current stimulation (tDCS). Our goal is to examine the safety and efficacy of this device when used as an add-on or adjunctive treatment to the usual treatments during the inpatient stay.

Conditions

• Suicide
• Depression
• Anxiety
• Insomnia
• Agitation

Interventions

Type	Name	Description
DEVICE	Alpha-Stim®.	cranial electrical stimulation
BEHAVIORAL	Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale	A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-01-22
• Completion: 2018-01-22
• First posted: 2016-07-27
• Last updated: 2019-12-26
• Results posted: 2019-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study