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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03243084
Other study ID # 17-0870
Secondary ID R01MH101547
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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