Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients
Phase: NA
Conditions: Suicide, Depression, Anxiety, Insomnia, Agitation
Sponsor: University of Maryland, Baltimore

 
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Study Protocol 
 
Protocol Title: Cranial electric stimulation (CES) to modify suicide risk 
factors in psychiatric inpatients   
 
Study No.: HP-00065640, Date 6th February 2016 
Principal Investigator: Nithin Krishna MD, 410-328-6610, 410-328-5386 (24 hour access) 
 
 
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 1/1000th of the current used for electroconvulsive therapy (ECT) and 
1/10th to 1/20th of the 1-2 milli amperes 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 Type   Interventional  
 
Study Phase 4  
 
Study Design    
 
Allocation: Randomized Intervention Model: Parallel Assignment  
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)  
Primary Purpose: Treatment  
 
Conditions:  
• 
Suicide  
• 
Depression  

 
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• 
Anxiety  
• 
Insomnia  
• 
Agitation  
 
Intervention   Device: Alpha-Stim®. Study Arms • Experimental: Adjunctive CES  
 
CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at 
baseline (i.e., pre-treatment), twice a week and at the end of the study.  
 
Intervention: Device: Alpha-Stim®.  
 
Sham Comparator: Sham control CES  
 
For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for 
both the sham group and the active CES group. The current intensity will be preset and locked by the 
manufacturer. The sham devices will appear identical to the active device.  
 
Intervention: Device: Alpha-Stim  
 
 
Primary Outcome Measures: 
 
Change in the modifiable suicide risk factors (MSRF's) 
 
To assess the efficacy of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to 
reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical 
trial. The primary efficacy outcome measure will be change in the modifiable suicide risk factors 
(MSRF's) as indicated by a summed global score from rating scales measuring the MSRFs that include 
depression (Montgomery-Åsberg Depression Rating Scale), anxiety (Hamilton Anxiety Rating Scale), 
insomnia (The Pittsburgh Sleep Quality Index) and agitation (Agitated Behavior Scale). 
 
 
Assess adverse effects and safety  
 
To assess safety of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce 
suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. 
The primary safety outcome measure will be responses to an adverse effect assessment questionnaire 
(GASE questionnaire). 
 
Secondary Outcome Measures: 
 
Assess length of stay