Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
McLean Hospital
Belmont, Massachusetts, United States
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.
Time frame: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
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.
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
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.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment