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Completed

NCT Number: NCT01860677

The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood

Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.

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Key information

Conditions

Mood

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fisher Wallace Cranial Stimulator

Device

The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Mending Minds Foundation

Registry information

Official study title

The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood: An fMRI/MRS Study

Acronym: CES

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 23, 2013
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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