Brainwave Changes and Cranial Electrotherapy Stimulation
Effects of Cranial Electric Stimulation on Brain Wave Activity: A Pilot Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
This pilot study will collect data from properly consented and subsequently enrolled subjects in the Psychiatric Continuity Service (PCS). All PCS programs provide both group and individual therapy designed to address various chronic mental health disorders such as major depressive disorder, anxiety, and post-traumatic stress disorder (PTSD). Group therapy and education focus on how chronic mental health disorders develop, the recovery process and psychosocial stressors that may contribute to both improvement in functioning and declines. Every patient is different with regard to how his or her program is tailored, but everyone receives weekly individual counseling from behavioral health providers (psychiatrists, psychologists and clinical social workers). PCS works in tandem with other treatment providers, case managers and chains of command. PCS is also equipped to transfer patients in need to higher levels of care in cases of emergency.
All prospective subjects will be active duty service members who are enrolled in PCS. Subjects will be recruited by the Associate Investigator (AI) or Principal Investigator (PI). The primary outcome measure is the exploration of changes in specific brain wave activity in response to a Cranial Electrotherapy Stimulation (CES) intervention.
Subjects who agree to participate in the study will complete a consent and Health Insurance Portability and Accountability Act (HIPAA) form and baseline questionnaires. In addition, since the fetal effects of the CES device is not known;, female subjects will have to present a negative pregnancy test within one week of the research intervention. Those female subjects to which pregnancy is unlikely (i.e. hysterectomy), will be excluded from a pregnancy test if this information can be verified medically. will self-report regarding as it applies menstrual cycle length and birth control method used within the last two weeks.
The intervention will take place during clinic hours. This will be a one-time intervention that will last approximately 1 to 1 ½ hours. The AI will prepare the CES device, briefly explain the function, and place the CES ear clips on the subject. The CES device will not be turned on at this point. This is similar to clinic practice, however in clinical practice any PCS staff trained in the use of the CES device may prepare and administer the CES device to the patient.
Next the AI will prepare the MindSet EEG device, ensure that it is functioning properly, and obtain signal acquisition. The AI will then explain the brainwave headset (MindSet) to the subject and properly place the headset on their head. Next a series of computer led activities to reduce extraneous artifacts (such as eye blink and muscle movement) will be completed by the subject. Following this, a baseline test measuring brainwave frequencies will be completed by the subject. This will last 30 seconds. Once this is completed, the CES device can be turned on and activated for 20 minutes. The CES micro amperage will be set by the subject based on therapeutic dose and locked in place on the CES device. Immediately following the completion of the 20 minute CES session, an EEG brainwave measure will be completed. Additional brainwave measure will be taken 5 minutes and 10 minutes post the CES session. Each of these brainwave measures will last 30 seconds.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inclusion Criteria All prospective subjects will be active duty service members who are enrolled in PCS
Exclusion Criteria:
• Subjects will be excluded who have a seizure disorder, a cardiac pacemaker, or active untreated vertigo.
- Subjects will be excluded if they have used CES the day of the study. However, they may participate in the study the following day.
- Female subjects who are or who suspect they may be pregnant.
- Subjects will also be excluded who are clinically judged by the investigators to be actively suicidal or have another psychiatric condition that would require inpatient hospitalization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Brainwave
Brainwave analysis after cranial electric stimulation
|
Micro amperage TCDS
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative EEG Analysis
Time Frame: Quantitative EEG collected at baseline (immediately before stimulation), immediately after 20 minutes of stimulation and then 5 and 10 minutes post stimualtion. Each of these four measures will record 30 seconds of brainwave activity
|
The investigators used a commercially available EEG headset (Neurosky MindSet) in combination with EEG software (SmartMind) to obtain and analyze the Quantitative EEG from the subjects.
The combination of the EEG headset with the software identified the five brainwave frequencies that are clinically relevant in studying EEG activity: Alpha, Beta, Delta, Gamma, and Theta.
The combination of the headset and software reported changes in brainwave amplitude in microvolts for each brainwave frequency.
Alpha waves increase with relaxation and drowsiness; and Beta waves, increase with wakefulness and concentration.
Delta and Theta waves increase during meditative states and Gamma may suggest brain synchronicity.
|
Quantitative EEG collected at baseline (immediately before stimulation), immediately after 20 minutes of stimulation and then 5 and 10 minutes post stimualtion. Each of these four measures will record 30 seconds of brainwave activity
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 418467-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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