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.
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.
- Conditions
- Psychiatric Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Brainwave | Experimental | Brainwave 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.
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.
- First posted2 Oct 2017
- Study start27 May 2016
- Primary completion10 May 2017
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cranial Electric Stimulation on Brain Wave Activity: A Pilot Study
- ClinicalTrials.gov ID
- NCT03298308
- Acronym / sponsor ID
- 418467-1
- Conditions
- Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 27 May 2016 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study explored relationships between cranial electric stimulation and brainwave changes.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brainwave | Experimental | Device: Cranial Electric StimulationBrainwave analysis after cranial electric stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion Criteria All prospective subjects will be active duty service members who are enrolled in PCS
Key exclusion criteria (4 listed)
- • Subjects will be excluded who have a seizure disorder, a cardiac pacemaker, or active untreated vertigo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial Electric StimulationMicro amperage TCDS | Device | Brainwave |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Derived from this study: PubMed 29360291Lande 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.