MoodCESNCT01860677
The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood
A study testing Fisher Wallace Cranial Stimulator in people with Mood, run by Mclean Hospital at 1 site in United States.
Trial summary
Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood
- What is being tested?
- Fisher Wallace Cranial Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21 to 55 years old
- Otherwise physically healthy (normal physical exam, ECG, blood and urine chemistries)
- Female participants must use medically approved method of contraception. If barrier method is used, they must agree to using two methods simultaneously (e.g., diaphragm and condom).
- If on antidepressant or antianxiety medication, must be on a stable prescription regimen with no intentions to change drugs or dose during the next 11 weeks.
Who cannot join
- Opiate maintenance (e.g., methadone or buprenorphine)
- Drug use (other than nicotine, alcohol, or marihuana) greater than 50 lifetime uses.
- Meets criteria for current drug abuse or dependence (other than nicotine, alcohol, or marihuana). Past abuse/dependence (greater than 3 years) is acceptable.
- Meets criteria for alcohol dependence. Past abuse/dependence (greater than 3 years) is acceptable. They may meet criteria for alcohol abuse.
- Physical health problems
- History of significant cardiac problems
Show all 12Show fewer
- History of seizures
- Pregnancy
- Persons with a demand-type cardiac pacemaker
- Persons receiving vagus nerve simulation
- Persons receiving deep brain stimulation
- Participants cannot have any conditions that are contraindicated for MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood: An fMRI/MRS Study
Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.
Read the detailed description
The advent of an appreciation that alternative and complementary practices can have some beneficial effect on health has prompted the question of whether there are empirical measures of improvement that do not rely solely on subjective reports. The present study proposes to explore whether transcranial stimulation (or cranial electrotherapy stimulation; CES) using an FDA-approved device can alter brain function, mood and responses to cognitive tasks.
- Conditions
- Mood
- Being tested
- Fisher Wallace Cranial Stimulator
- Keywords
- cranial stimulation, BOLD (Blood Oxygenation Level Dependent), fMRI (Functional Magnetic Resonance Imaging), spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisher Wallace Cranial StimulatorDevice
The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA. Receives: Device: Fisher Wallace Cranial Stimulator |
| Sham stimulation | Placebo comparator | Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. Receives: Device: Fisher Wallace Cranial Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits
Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment.
The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption.
Measured: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Secondary outcomes (3)
BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only
Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment.
The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption.
Measured: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm
Positive and Negative Affect Schedule (PANAS), as defined by Watson et al. (1988), range between 10 and 50 points. Anchors of "not at all" (10) to "most ever" (50) were used to rank each measure. Change compares post-treatment to pre-treatment.
Positive Affects included the following terms: Attentive, Active, Alert, Excited, Enthusiastic, Determined, Inspired, Proud, Interested, and Strong. Negative Affects included the following terms: Hostile, Irritable, Ashamed, Guilty, Distressed, Upset, Scared, Afraid, Jittery, and Nervous. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome.
Measured: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Visual Analogue Scale (VAS) ranges from 0-100. Anchors of "not at all" (0) to "most ever" (100) were used to rank the following:
anxious, sleepy, dizzy, relaxed, physical symptoms, confused, sluggish, energetic, fatigued, and stressed. Change compares post-treatment to pre-treatment.
Measured: within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MoodStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mending Minds Foundation
- Responsible party
- Principal investigator, Scott Lukas, Mclean Hospital
- Investigators
- Scott E Lukas, PhD, Principal investigator, McLean Imaging Center, McLean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860677
- Sponsor's protocol ID
- P-001567
- Acronym
- CES
- Status last verified
- May 2017
- First submitted
- 20 May 2013
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gilula MF, Barach PR. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. South Med J. 2004 Dec;97(12):1269-70. doi: 10.1097/01.SMJ.0000136304.33212.06. No abstract available.
PubMed 15646771Smith RB (2006) Cranial electrotherapy stimulation: Its first fifty years, plus three: a monograph. Oklahoma: Tate Publishing & Enterprises
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood: An fMRI/MRS Study
- ClinicalTrials.gov ID
- NCT01860677
- Acronym / sponsor ID
- CES / P-001567
- Conditions
- Mood
- Keywords
- cranial stimulation, BOLD (Blood Oxygenation Level Dependent), fMRI (Functional Magnetic Resonance Imaging), spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Mending Minds Foundation
- Study start
- May 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.
Detailed description
The advent of an appreciation that alternative and complementary practices can have some beneficial effect on health has prompted the question of whether there are empirical measures of improvement that do not rely solely on subjective reports. The present study proposes to explore whether transcranial stimulation (or cranial electrotherapy stimulation; CES) using an FDA-approved device can alter brain function, mood and responses to cognitive tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: Fisher Wallace Cranial StimulatorThe Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA. |
| Sham stimulation | Placebo comparator | Device: Fisher Wallace Cranial StimulatorParticipants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 21 to 55 years old
- Otherwise physically healthy (normal physical exam, ECG, blood and urine chemistries)
- Female participants must use medically approved method of contraception. If barrier method is used, they must agree to using two methods simultaneously (e.g., diaphragm and condom).
- If on antidepressant or antianxiety medication, must be on a stable prescription regimen with no intentions to change drugs or dose during the next 11 weeks.
Key exclusion criteria (12 listed)
- Opiate maintenance (e.g., methadone or buprenorphine)
- Drug use (other than nicotine, alcohol, or marihuana) greater than 50 lifetime uses.
- Meets criteria for current drug abuse or dependence (other than nicotine, alcohol, or marihuana). Past abuse/dependence (greater than 3 years) is acceptable.
- Meets criteria for alcohol dependence. Past abuse/dependence (greater than 3 years) is acceptable. They may meet criteria for alcohol abuse.
- Physical health problems
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 |
|---|---|---|
| Fisher Wallace Cranial StimulatorThe Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. | Device | Active stimulation, Sham stimulation |
Primary outcome
BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits
Time frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption.
3 secondary outcomes
BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only
Time frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm
Time frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
Time frame: within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15646771Gilula MF, Barach PR. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. South Med J. 2004 Dec;97(12):1269-70. doi: 10.1097/01.SMJ.0000136304.33212.06. No abstract available.
- BackgroundSmith RB (2006) Cranial electrotherapy stimulation: Its first fifty years, plus three: a monograph. Oklahoma: Tate Publishing & Enterprises
- 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.
Scott E Lukas, PhD principal investigator
McLean Imaging Center, McLean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fisher Wallace Cranial Stimulator in people with Mood, run by Mclean Hospital at 1 site in United States.
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 4 inclusion and 12 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits (time frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment). 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 NCT01860677, which also lists 2 linked publications.
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 14 Jun 2017; AzTrials last refreshed its copy on 31 Oct 2026.