Recruiting

tDCS & Chronic Pain

Sponsor:

University of Arizona

Code:

NCT05863494

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation (tDCS) sham

Study Details

Brief 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.

Conditions

Chronic Pain

Study ID

NCT05863494

Start date

Jun 1, 2023

Status verified date

May, 2023

Completion date

Oct, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (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 the last 3 months (except nicotine and caffeine).
  • Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
  • Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  • Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk 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 for safety reasons: a) It is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject who cannot tell us immediately of any side effects; Note that translation of the proposed ACT activity into English has not been validated and that we cannot be confident 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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

For visits 1-5 (tDCS treatment visits), the investigators will start with 0.5mA ramping up to 0.75mA for 5 minutes. Followed by a brief (8 sec) EEG recording. Then, the investigators will apply .75mA to 1mA for 5 minutes. This will also be followed by 8 second EEG recording. The final application of current will be 1mA to 1.75mA for 10 minutes followed again by 8 second EEG recording.

sham comparator: Sham

For visits 1-5 (tDCS treatment visits),The sham group will receive 1 minute from 0.0mA to no more than 0.5mA at the initiation of the treatment after which the current will be turned off. They will still proceed with the full 20 minutes as does the treatment group but no current will be further applied as indicated in the treatment group. They will still receive EEG readings at the indicated 8 seconds after "current" is applied but will not receive the current. This is to maintain a blind trial. 0.5mA is negligible current but mimics treatment with an initial small tingle.

Interventions

Transcranial Direct Current Stimulation (tDCS)

TDCS is a non-invasive brain stimulation that uses electrical currents to stimulate specific areas of the brain. A constant, low-intensity current passes through two to four electrodes, which can be placed on various locations on the head, to modulate neuronal activity. tDCS can administer anodal and cathodal stimulation to excite (depolarization) or inhibit (hyperpolarization) neuronal activity, respectively. Using low-amplitude direct currents applied via scalp electrodes to alter cortical excitability is not a novel concept. This non-pharmacological approach has held promise for decades as a way to treat a plethora of neurological and psychiatric disorders. Although tDCS is not currently FDA-approved it is considered a non-significant-risk therapy with no record of serious adverse effects.

Transcranial Direct Current Stimulation (tDCS) sham

TDCS is a non-invasive brain stimulation that uses electrical currents to stimulate specific areas of the brain. A constant, low-intensity current passes through two to four electrodes, which can be placed on various locations on the head, to modulate neuronal activity. tDCS can administer anodal and cathodal stimulation to excite (depolarization) or inhibit (hyperpolarization) neuronal activity, respectively. Using low-amplitude direct currents applied via scalp electrodes to alter cortical excitability is not a novel concept. This non-pharmacological approach has held promise for decades as a way to treat a plethora of neurological and psychiatric disorders.

The sham group will receive 1 minute from 0.0mA to no more than 0.5mA at the initiation of the treatment after which the current will be turned off. This is to maintain a blind trial. 0.5mA is negligible current, but mimics treatment with an initial small tingle.

Primary outcome measure

  • Determine the impact of tDCS on pain in chronic pain participants using pain perception scale [ Time Frame: 14 months ]
  • Determine the impact of tDCS on the self-reported reduction in opioid use, or the desire for opioid use. [ Time Frame: 14 months ]
  • Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing blood pressure [ Time Frame: 14 months ]
  • Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing heart rate [ Time Frame: 14 months ]
  • Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing heart rate [ Time Frame: 14 months ]

Central Contacts and Locations

Central contacts

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Principal Investigator:

Allison J Huff, DHed

More Information

Sponsor

University of Arizona

Last update posted

May 18, 2023

Last verified

May, 2023

Keywords

  • chronic pain
  • transcranial direct current stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2023-05-18.