Cranial Electrical Stimulation (CES) & EEG - A Pilot Project for Alternative Payment Contracting
Lead Investigator: Michael G. Conner, PsyD
CES is a safe, proven and side-effect free option for the treatment of depression, anxiety and insomnia.
CES has none of the side effects that are invariably a result of taking antidepressant medications. There are more than 100 articles and research publications on this form of treatment.
Cranial electrotherapy stimulation (CES) is a form of neurostimulation that delivers a extremely small, pulsed, current using electrodes that can be clipped to ear lobes or placed on the neck using conductive pads. CES is used with the intention of treating a variety of conditions primarily anxiety, depression and insomnia. CES is also used to alleviate specific symptoms common with those conditions such rumination and distractibility. CES has been suggested as a possible treatment for headaches, fibromyalgia, smoking cessation and opiate withdrawal, but thus far there is little research examining CES effectiveness on those specific conditions.
CES is listed with FDA as a Class 3 device (Class 2 is pending)
In the United States, CES technology is classified by the Food and Drug Administration (FDA) as a Class 3 medical device and can only be used as a treatment when dispensed or prescribed by a healthcare professional. Depending upon state regulations, qualified healthcare professionals may include counselors, social workers, psychologists, nurses, nurse practitioners, physicians, or physician assistants, who provide behavioral and mental health services and are licensed by the State in which they practice.
The technology of CES devices is regulated. They may only be used by patients when they operate within specific parameters.
Those typically include device operation at:
- 9 volts or less
- 500 microamps or less
- 100 hz or less.
- 20% to 50% duty cycle
Mentor Research Institute is investigating the effectiveness of CES tools and new technology to make these devices affordable to patients.
Mentor Research Institute is developing an outcome and exploratory research project involving a CES device.
This research will include:
- Comprehensive medical and mental health screening and progress measures
- Multimodal Treatment of Panic and Anxiety Disorders.
- Use of an EHR and an Analytic System.
The Protocol consists of:
- Anxiety and Stress Education.
- Pairing stimulus with multiple calming responses
- Clarity-CES (increase alpha, reduce beta and delta)
- Breathing and vagus nerve stimulation strategies.
- Calm imagery reinforced with dual attention stimulation.
- Developing cognitive constructs to counter fear.
- EMDR and/or cognitive behavior therapy-as appropriate to patient
- Biofeedback to measure and guide treatment
Frequency of Data collection
The Frequency of data collection includes:
- Weekly progress questionnaire
- Per-treatment-session prompts/questions
- Rate of Change
- Effect Size
- Reliable Change Index
- Severity Adjusted Effect Size
- Co-morbidity of Anxiety with Other Disorders
- Therapist patient alliance measures
- Patient satisfaction measures
Institutional Review Board
An Institutional Review Board is not necessary because
- There are no monetary incentives.
- The study involves voluntary use of protocols
- The study is non- experimental
- There are no placebos
- The study is passive and involves naturalistic observation data collections
- Incident reporting will be be to MRI and providers
- Patients will have full information and informed consent
- Patients must rent or purchase Clarity-CES.