Clinical trial NCT01860677: The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood
Official title: The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood: An fMRI/MRS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Keywords: cranial stimulation
BOLD (Blood Oxygenation Level Dependent)
fMRI (Functional Magnetic Resonance Imaging)
spectroscopy
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Mending Minds Foundation
First posted: 2013-05-23
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits
timeFrame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Secondary outcomes:
measure: BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only
timeFrame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
measure: Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm
timeFrame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
measure: Change in Visual Analogue Scale (VAS) in Active Stimulation Arm
timeFrame: within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: McLean Imaging Center, McLean Hospital
name: Scott E Lukas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Smith RB (2006) Cranial electrotherapy stimulation: Its first fifty years, plus three: a monograph. Oklahoma: Tate Publishing & Enterprises