tDCS and Impulsivity

May 2, 2023 updated by: Allison J Huff Macpherson, University of Arizona

Impulsivity Mediation Using Transcranial Direct Current Stimulation Paired With Acceptance Commitment Therapy as an Adjunctive Therapy for Substance Use Disorder

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the proposed study is to determine the impact of tDCS on impulsivity in SUD subjects. The long-term goal of the study is to address the underlying neurobiological deficiencies caused by SUD and provide a more personalized adjunctive SUD treatment.

Aim 1 will establish the extent of change to brain waves during tDCS+ACT treatment sessions in both arms while also performing the stop signal task. This aim will be achieved by capturing baseline EEG readings of the entire brain for subjects in both arms and also capturing EEG readings during the treatment phase and at the final study visit 1-week post and comparing between and within results.

Aim 2 will determine whether a change to self-reported impulsiveness occurs as a result of tDCS or tDCS and ACT exercise accompanied by the stop signal task. The investigators will achieve this aim by comparing the baseline Barratt Impulsiveness Scale (BIS-11) survey results of subjects in treatment and placebo arms to BIS-11 survey results on the final day of the 5 days of treatment and one week later, enabling investigators to determine any short-term change or durable change to impulsivity.

Aim 3 will measure whether the tDCS system, tKIWI, results in any unwanted side effects or adverse events. The investigators will achieve this aim by monitoring subjects' vitals during the entire session and evaluating results of a questionnaire after each treatment session and after the final study visit, enabling us to capture reported discomfort.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18-79 years old
  • Gender: Any
  • Ethnicity: Any
  • Diagnosis of substance use disorder and a recent history of substance use (<24 months last use), but not currently reporting use.

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
  • primary drug of choice alcohol or marijuana
  • taking antipsychotic drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment

The anode and cathode are two large 5 cm by 5 cm gel-based pads which are placed on the scalp. 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.

In order to help minimize the stinging feel of the treatment, we have chosen to ramp up time and frequency. For visits 2-6 (tDCS treatment visits), we will start with 0.5mA ramping up to 0.75mA for 5 minutes. Followed by a brief (8 sec) EEG recording. Then, we will apply 0.75mA to 1mA while watching the ACT video for 5 minutes. This will also be followed by 8 second EEG recording. The final application of current will be 1.0mA to 1.75mA for 10 minutes followed again by 8 second EEG recording.
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 (

Other Names:
  • tKIWI
Sham Comparator: Sham
The sham group will receive ramped up current from 0.0mA not to exceed 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in brain waves from before and after treatment measured by the EEG component of the tDCS device
Time Frame: 14 months
Will measure the change in brain waves during tDCS+ACT treatment sessions in both arms. This aim will be achieved by capturing baseline EEG readings of the entire brain for subjects in both arms and also capturing EEG readings during treatment phase and at final study visit 1 week post and comparing between and within results.
14 months
Change in impulsivity from treatment using Barratt Impulsiveness Scale (BIS-11) survey
Time Frame: 14 months
Comparing the baseline Barratt Impulsiveness Scale (BIS-11) survey results of subjects in treatment and placebo arms to BIS-11 survey results on the final day of the 5 days of treatment and one week later, enabling investigators to determine any short-term change or durable change to impulsivity. BIS-11 survey is a 30 question survey to measure impulsiveness. The answers to the questions are ranked on a scale of 1 to 4, 1 being never/ unlikely and 4 being almost always/ always. The tally of all questions is collected, and the points range from 30 to 120, the higher the score the higher level of impulsiveness.
14 months
Side effects or adverse events from the study device using vitals signs (blood pressure, heart rate, and temperature).
Time Frame: 14 months
Will measure whether the tDCS system, tKIWI, results in any unwanted side effects or adverse events. We will achieve this aim by monitoring subjects' vitals during the entire session (blood pressure, heart rate, and temperature), enabling investigators to capture reported discomfort.
14 months
Side effects or adverse events from the study device using a multiple choice side effect questionare
Time Frame: 14 months
A multiple choice side effect survey will be given to all participants during study visits 1 through 5. The questions ask about possible side effects such as pain, redness, and tingling. If the participant answers yes they experienced the side effect, they are asked to rank it (barley, a little, very) and the duration of the side effect (continued after treatment, stopped when treatment stopped, stopped during treatment). This will be used to asses risk and side effects of the device.
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Allison J Huff, DHEd, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

October 11, 2023

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The deidentified raw data will be stored for future research. The results will be published and shared with the industry partner, ni20, inc.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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