Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

University of North Carolina, Chapel Hill21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Chronic Low Back Pain

Interventions

XCSITE100 Stimulator tACSDEVICE

Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in Heart Rate Variability Before and After 40-minute Stimulation

Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation

Time frame: before and after 40-minute stimulation at each session

Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation

Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation

Time frame: 5 minute recordings before and after each 40-minute stimulation at each session.

Secondary Outcomes

Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation

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)

Time frame: before and after 40 minute stimulation session