Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Transcranial Alternating Current Stimulation in Chronic Low Back Pain: A Pilot Study

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: XCSITE100 Stimulator Sham
* Device: XCSITE100 Stimulator tACS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant will receive sham stimulation and 10Hz tACS stimulation at two separate sessions. The order will be randomized (ie, half the participants will receive sham stimulation at the first session and 10Hz tACS stimulation at the second session, and the other half will receive 10Hz tACS stimulation at the first session and sham stimulation at the second session).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham tACS<br>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. | Device: XCSITE100 Stimulator Sham<br>* The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session<br>* Other names: Sham tACS;|
| Active Comparator: Active 10 Hz tACS<br>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. | Device: XCSITE100 Stimulator tACS<br>* 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<br>* Other names: tACS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 5 minute recordings before and after each 40-minute stimulation at each session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | before and after 40 minute stimulation session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tACS, transcranial alternating current stimulation, low back pain, chronic pain, alpha oscillations, heart rate variability