Cranial Electrotherapy Stimulation (CES) for Soldiers Wit... | NCT00866411

Studies
Cranial Electrotherapy Stimulation (CES) for Soldiers With Combat-Related Symptoms

NCT00866411

Sponsor

Brooke Army Medical Center

Status

Unknown status

Last Update Posted

Mar 20, 2009Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Combat Related Symptoms
Irritability
Anger

Interventions

cranial electrotherapy stimulation (CES) with Alpha-Stim
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

May 2009Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Mar 19, 2009

First Submission Date that Met QC Criteria

Mar 19, 2009

First Posted Date

Mar 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2009

Last Update Posted Date

Mar 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this double-blind randomized control research study is to determine if CES given in a group setting for soldiers experiencing irritability is effective to reduce the symptom of irritability.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cranial electrotherapy stimulation (CES) with Alpha-Stim	Procedure	three weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments)		cranial electrotherapy stimulation CES Alpha-Stim bioelectric medicine
placebo	Procedure	three weeks of placebo treatment via a double-blinded procedure so that neither the Soldier nor the study investigators will know whether the Soldier is receiving the actual treatment or placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Irritability Visual Analog Scale		Baseline, daily x 3 weeks, 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
State Anxiety Scale		Baseline, 3 weeks, 4 weeks
Pittsburgh Sleep Quality Index		Baseline, 3 weeks, 4 weeks
Epworth Sleepiness Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Soldiers over 18 years old or emancipated minors willing to sign an informed consent and complete all protocol requirements.
Soldiers who score 4 or greater on the visual analog scale for irritability

Exclusion Criteria:

Seizure disorders.
Pregnancy. All female Soldiers will verify in the informed consent that they are not currently pregnant. Safety of stimulation has not been established during pregnancy and therefore we will exclude women who are or want to become pregnant during the course of the study.
Concomitant therapy with an investigational drug or device, or participation in an investigational drug or device study within one month prior to entering this study
Patients with a pacemaker or implanted defibrillator. The Alpha-Stim 100 may effect the operation of cardiac pacemakers (particularly demand type pacemakers) and therefore this population will be excluded from this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mona O Bingham, PhD	Brooke Army Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carl R. Darnall Army Medical Center	Recruiting	Fort Hood	Texas	76544	United States

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D003863	Depression
D010146	Pain
D020447	Parasomnias

Ancestor Terms

ID	Term
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided