N/A
N=21
Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy
Chronic Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03243084 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Change in Heart Rate Variability Before and After 40-minute Stimulation — 0.206; -0.01 ms^2 — p=.319
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- XCSITE100 Stimulator Sham (Device); XCSITE100 Stimulator tACS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Heart Rate Variability Before and After 40-minute Stimulation |
0.206; -0.01 | .319 |
| PRIMARY Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation |
0.03; 0.4 | — |
| SECONDARY Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation |
-0.178; 0.18 | .0488 sig |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03243084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.