tDCS and Impulsivity

NCT05845164 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-06

No results posted yet for this study

Summary

Substance use disorder (SUD) affects more than 23 million Americans and claims more than 70,000 lives annually. With 40-60% relapse rate, SUD patients are high hospital utilizers, 65% of the incarcerated population, and are at high-risk for overdose and deaths. There is a pressing need for research in this area to advance beyond traditional pharmacological and behavioral therapies toward a greater focus on the mechanisms of risk for relapse and to improve personalization for SUD treatment.

Neuromodulation has shown promise to stimulate neuronal growth without any of the side effects of medications or electroconvulsive therapy. Using transcranial direct current stimulation (tDCS) to modulate cortical activity has shown to be a viable therapy in medicine-resistant depression, to reduce opioid cravings, and impulse control.

The proposed research plans to recruit 30 subjects with a history of substance use disorder (SUD). This may include a history of addiction to opioids, cocaine, and barbiturates. Addiction to alcohol and cannabinoids (marijuana) will be excluded from this study. Following recruitment and consent, the subject will be administered an EEG, Acceptance Commitment Therapy exercise followed by EEG, and a BIS-11 Survey measuring levels of impulsivity. During the next week, the patient will undergo 5 visits consisting of a pre-EEG, tDCS, and post-EEG. Half of the subjects (n=15) will receive treatment, while the other half will be in a sham group. After the completion of the 5 tDCS visits, the patient will again be administered an EEG, ACT exercise followed by EEG, and a final BIS-11 survey measuring for end impulsivity levels.

Conditions

Interventions

DEVICE

tDCS

EEG: The tKIWI uses sensors placed on specific locations of the head for the EEG reading. tDCS: The anode and cathode are two large 5 cm by 5 cm gel-based pads which are placed on the scalp. This reduces the risk of burn or irritation and increases conduction. The 2 electrodes are connected to the tKIWI device which delivers a low intensity electrical current (\</=2A), thereby polarizing membrane potential of neurons in the stimulated area. Current that flows from the cathode to the anode has an inhibitory effect on the stimulated area, while current that flows from the anode to the cathode is typically excitatory. We will be initiating bilateral stimulation of the Dorsolateral pre-frontal cortex (DLPFC), which has been shown in the literature to elicit a significant decrease in ambiguous risk-taking behavior in healthy human subjects and a decrease in impulsivity on a non-ambiguous risk task.

DEVICE

tDCS Sham

EEG: The tKIWI uses sensors placed on specific locations of the head for the EEG reading. The sham group will receive ramped up current from 0.0mA to no more than 0.5mA for the first minute at the initiation of each of the three "ramp ups," 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. The current delivered by tDCS is not strong enough to trigger an action potential in a neuron; instead its "sub-threshold" changes the pattern of already active neurons.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Allison J Huff, DHEd · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-07-01
Completion
2023-10-11

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845164 on ClinicalTrials.gov