Clinical trial NCT03243084: Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy
Official title: Effect of Transcranial Alternating Current Stimulation in Chronic Low Back Pain: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: tACS
transcranial alternating current stimulation
low back pain
chronic pain
alpha oscillations
heart rate variability
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-08-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Change in Heart Rate Variability Before and After 40-minute Stimulation
timeFrame: before and after 40-minute stimulation at each session
measure: Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation
timeFrame: 5 minute recordings before and after each 40-minute stimulation at each session.
Secondary outcomes:
measure: Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation
timeFrame: before and after 40 minute stimulation session
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Karen McCulloch, PhD, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prim JH, Ahn S, Davila MI, Alexander ML, McCulloch KL, Frohlich F. Targeting the Autonomic Nervous System Balance in Patients with Chronic Low Back Pain Using Transcranial Alternating Current Stimulation: A Randomized, Crossover, Double-Blind, Placebo-Controlled Pilot Study. J Pain Res. 2019 Dec 11;12:3265-3277. doi: 10.2147/JPR.S208030. eCollection 2019.
citation: Ahn S, Prim JH, Alexander ML, McCulloch KL, Frohlich F. Identifying and Engaging Neuronal Oscillations by Transcranial Alternating Current Stimulation in Patients With Chronic Low Back Pain: A Randomized, Crossover, Double-Blind, Sham-Controlled Pilot Study. J Pain. 2019 Mar;20(3):277.e1-277.e11. doi: 10.1016/j.jpain.2018.09.004. Epub 2018 Sep 27.