Ignite Creation Date:
2024-05-06 @ 8:51 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02846740
Status:
TERMINATED
Last Update Posted:
2019-12-26
First Post:
2016-07-22
Brief Title:
Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No finding at halfway point of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11000 th of the current used for electroconvulsive therapy ECT and 110 th to 120 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None