Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy (BPS)

University of North Carolina (UNC)

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Device: XCSITE100 Stimulator tACS; Device: XCSITE100 Stimulator Sham

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03243084

17-0870

R01MH101547 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

21 participants in 2 patient groups

Sham tACS

Sham Comparator group

Description:

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.

Treatment:

Device: XCSITE100 Stimulator Sham

Active 10 Hz tACS

Active Comparator group

Description:

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.

Treatment:

Device: XCSITE100 Stimulator tACS