Transcranial Direct Current Stimulation and Chronic Pain

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

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• ni20

  collaborator UNKNOWN

• University of Arizona

  lead OTHER

Principal Investigators

• Allison J Huff, DHEd · University of Arizona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2023-07-31

Completion

2023-10-31

Countries

• United States

Study Locations