Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

Not Applicable

Completed

Interventions: Device: XCSITE100 Stimulator tACS
Device: XCSITE100 Stimulator Sham

Brief Summary: Chronic pain is a severe disabling problem within society, affecting 25-30% of the United States population.. Transcranial alternating current stimulation (tACS) has the potential to provide a treatment option that is safe, scientifically-supported, low-cost, and easy-to-administer method to effectively reduce symptoms in patients suffering from chronic pain. The purpose of this study is to test the feasibility of using tACS to treat patients with chronic pain, and to collect pilot efficacy as well as EEG and EKG biomarker data for optimizing the design of subsequent large-scale studies. The treatment rationale is to renormalize the presumed pathological structure of alpha oscillations in the prefrontal cortex (PFC) of patients with chronic pain.

Recruitment & Eligibility

Inclusion Criteria

Male or female, aged 18-65
Diagnosed with nonspecific chronic low back pain by clinician
BMI is less than 30
Suffered from chronic pain for > 6 months
Self-report pain measures >4
Meets criteria for low depression and suicide risk as defined by the Hamilton-Depression Rating Scale
Capacity to understand all relevant risks and potential benefits of the study (informed consent)
Not currently taking opioids, benzodiazepines, and anticonvulsant medications

Exclusion Criteria

Radicular Pain
Traumatic brain injury, Any brain devices/implants, including cochlear implants and aneurysm clips
History of major neurological or psychiatric illness, including epilepsy
(For females) Pregnancy or breast feeding
Diagnosis of eating disorder (current or within the past 6 months), Obsessive Compulsive Disorder (lifetime), or Attention-Deficit Hyperactivity Disorder (currently under treatment)

Arm && Interventions

Group	Intervention	Description
Active 10 Hz tACS	XCSITE100 Stimulator tACS	Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
Sham tACS	XCSITE100 Stimulator Sham	Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.

Primary Outcome Measures

Name	Time	Method
Change in Heart Rate Variability Before and After 40-minute Stimulation	before and after 40-minute stimulation at each session	Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation
Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation	5 minute recordings before and after each 40-minute stimulation at each session.	Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation

Secondary Outcome Measures

Name	Time	Method
Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation	before and after 40 minute stimulation session	Self reported pain rating using a Visual Analog Scale (VAS) ranging from 0-10 done before and after stimulation with '0' being no pain and '10' as bad as it could be. Lower values represent a better outcome. (Pain difference was normalized using modulation index to account for ordinal scale)