AzTrials
AzTrials

Psychiatric DisorderNCT03298308

Brainwave Changes and Cranial Electrotherapy Stimulation

A study testing Cranial Electric Stimulation in people with Psychiatric Disorder, run by Walter Reed National Military Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This pilot study explored relationships between cranial electric stimulation and brainwave changes. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Psychiatric Disorder
What is being tested?
Cranial Electric Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
27 May 2016to 10 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Inclusion Criteria All prospective subjects will be active duty service members who are enrolled in PCS

Who cannot join

  • • 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

About this study

Official title: Effects of Cranial Electric Stimulation on Brain Wave Activity: A Pilot Study

This pilot study explored relationships between cranial electric stimulation and brainwave changes.

Read the 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.

Being tested
Cranial Electric Stimulation
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cranial Electric StimulationDevice

    Micro amperage TCDS

Study groups in NCT03298308
Study groupRoleWhat they receive
BrainwaveExperimentalBrainwave analysis after cranial electric stimulation
Receives: Device: Cranial Electric Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative EEG Analysis

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start27 May 2016
  3. Primary completion10 May 2017
  4. Study completion10 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298308
Sponsor's protocol ID
418467-1
Status last verified
Sep 2017
First submitted
20 Sep 2017
Last updated
2 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lande RG, Gragnani CT. Prospective Study of Brain Wave Changes Associated With Cranial Electrotherapy Stimulation. Prim Care Companion CNS Disord. 2018 Jan 18;20(1):17m02214. doi: 10.4088/PCC.17m02214.

    PubMed 29360291

Questions about this trial

What is this clinical trial studying?

A study testing Cranial Electric Stimulation in people with Psychiatric Disorder, run by Walter Reed National Military Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298308, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in