Transcranial Direct Current Stimulation and Chronic Pain

Last updated: May 15, 2023
Sponsor: University of Arizona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation (tDCS) sham

Clinical Study ID

NCT05863494
STUDY00001896
  • Ages 18-79
  • All Genders

Study Summary

This clinical trial uses transcranial direct current stimulation (tDCS) using the patented tKIWI system to safely reduce self-reported chronic pain with little to no side effects to improve our understanding and ability to accurately diagnose pain disorders which would facilitate the development of pharmacologic and non-pharmacologic treatment modalities using deep learning architecture built into the tKIWI.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 18-79 years old
  • Gender: Any
  • Ethnicity: Any
  • Chronic pain (> 3-months); No current use of nonprescription opioids (< 1 month); Ableand willing to comply with scheduled visits and other study-related procedures tocomplete the study; Willing and able to give informed consent.

Exclusion

Exclusion Criteria:

  • Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eatingdisorder (current or within the past year); obsessive compulsive disorder (lifetime));mental retardation.
  • History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within thelast 3 months (except nicotine and caffeine).
  • Subject is on regular benzodiazepine medication which it is not clinically appropriateto discontinue.
  • Subject requires a rapid clinical response due to inanition, psychosis or high suiciderisk.
  • Neurological disorder or insult, e.g., recent stroke (CVA), which places subject atrisk of seizure or neuronal damage with tDCS.
  • Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts,abrasions, rash) at proposed electrode sites.
  • Female subject who is pregnant.
  • Participants who are not fluent in English will not be included in the trial forsafety reasons: a) It is usually not possible to have an interpreter reliablyavailable every weekday for up to 4 weeks and it is not safe to give tDCS to a subjectwho cannot tell us immediately of any side effects; Note that translation of theproposed ACT activity into English has not been validated and that we cannot beconfident that they would be accurately translated and validated.
  • Minors
  • Older than 79 years old
  • last use >24 months
  • history of EEG or any electrical implant (i.e. pacemaker)
  • history of Parkinson's, diagnosis of bipolar, schizophrenia/schizo-affective d/o, OCD,epilepsy, alzheimers
  • taking antipsychotic drugs

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Transcranial Direct Current Stimulation (tDCS)
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
October 31, 2023

Study Description

Pain is a severe and growing problem in the United States with more than 116 million Americans suffering from chronic pain and more than $635 billion is spent annually on pain and its related healthcare costs. Additionally, opioid addiction has become a national crisis with nearly 50,000 deaths every year as a result of opioid-involved overdoses and nearly $78.5 billion spent annually on opioid misuse and addiction. Currently available treatments for pain, namely opioid analgesics, have limited effectiveness and can lead to a significant number of side effects and complications including dependence, pharmacodynamic tolerance, sedation, gastrointestinal issues, respiratory depression, immunosuppression, and hormonal changes. Effectively treating pain requires an accurate assessment of pain, however current methods of diagnosing and evaluating pain depend on subjective self-reporting including the use of visual and numerical pain scales. The subjective nature of describing pain makes it virtually impossible to quantify and therefore difficult to treat and monitor. To overcome this subjectivity, through a non-invasive neuromodulation technique called transcranial direct current stimulation (tDCS) and deep learning, pain can be measured objectively using electroencephalograph (EEG) to assess and personalize treatment. The overarching goal of this project is to apply transcranial direct current stimulation (tDCS) as an alternative to opioids for the reduction in chronic pain. The investigator's long-term goal is to use these data to analyze EEG signals and generate personalized tDCS treatment in real time.

Connect with a study center

  • University of Arizona

    Tucson, Arizona 85719
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.