Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

Chronic Low Back Pain Clinical Trial

— BPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243084
• Other study ID #: 17-0870
• Secondary ID: R01MH101547
• Status: Completed
• Phase: N/A
• Start date: September 7, 2017
• Est. completion date: January 10, 2018

Study information

• Verified date: January 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 10, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• XCSITE100 Stimulator Sham
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
• XCSITE100 Stimulator tACS
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

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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