tDCS and Impulsivity

Sponsor

University of Arizona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05845164

Collaborator

(none)

Enrollment

Location

Arms

4.3

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders Substance Abuse Substance Use	Device: tDCS Device: tDCS Sham	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

30 participants will be recruited and randomly placed in either the treatment or the sham group. The randomization ratio is 1:1. Each participant has an equal chance of being assigned to each condition and each participant will be assigned to a condition independently of the other participants. The sample is small (15 each group), so in order to ensure random assignment, we will assign a unique number to every participant of the study's sample. Then, we will use a lottery method to randomly assign each number to the control or experimental group. Both the treatment and sham groups will participate in the ACT activity and the stop signal task which is administered at baseline and the final visit, but only the treatment group will receive tDCS.30 participants will be recruited and randomly placed in either the treatment or the sham group. The randomization ratio is 1:1. Each participant has an equal chance of being assigned to each condition and each participant will be assigned to a condition independently of the other participants. The sample is small (15 each group), so in order to ensure random assignment, we will assign a unique number to every participant of the study's sample. Then, we will use a lottery method to randomly assign each number to the control or experimental group. Both the treatment and sham groups will participate in the ACT activity and the stop signal task which is administered at baseline and the final visit, but only the treatment group will receive tDCS.

Masking:

Single (Participant)

Masking Description:

Only the study staff will have access to the randomization information and study participants in each arm will not be informed which arm they are in. The sham group will receive 10 seconds of .5mA 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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Oct 11, 2023

Arms and Interventions

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 (</=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. 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.

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 (</=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.

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.

Outcome Measures

Primary Outcome Measures

Difference in brain waves from before and after treatment measured by the EEG component of the tDCS device [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.
Change in impulsivity from treatment using Barratt Impulsiveness Scale (BIS-11) survey [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.
Side effects or adverse events from the study device using vitals signs (blood pressure, heart rate, and temperature). [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.
Side effects or adverse events from the study device using a multiple choice side effect questionare [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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