Temporal Interference Methods for Addiction Treatment
Indiana University
Summary
This clinical study is testing whether a new non-invasive brain stimulation method, called temporal interference (TI), can reduce nicotine cravings and usage in people who vape. TI delivers mild electrical currents to the scalp in a way that targets deep brain areas involved in addiction, without the need for surgery. In this randomized controlled trial, participants will be assigned to one of three groups: TI stimulation to the nucleus accumbens, TI stimulation to the anterior insula, or a placebo (sham) condition. Each participant will attend a single stimulation session after 8 hours of nicotine abstinence and will use a custom vape device that measures real-time nicotine inhalation. Craving levels will be reported during and after the session. The study aims to determine whether TI to the insula or nucleus accumbens is more effective at decreasing cravings and nicotine inhalation, and whether either is more effective than sham stimulation. For one week after the session, participants will use a smartphone app to track nicotine use and cravings. The primary hypothesis is that TI stimulation to deep brain regions will reduce both nicotine craving and actual use, immediately after stimulation and over the following week, compared to the sham condition.
Description
Substance use disorders (SUDs) are difficult to treat effectively, with high relapse rates despite behavioral and pharmacological interventions. Previous clinical and case studies have shown that direct stimulation of deep brain regions-including the nucleus accumbens (NAcc) and anterior insula (AI)-can produce rapid, sustained reductions in addictive behaviors. Deep brain stimulation (DBS) of the NAcc has resulted in remission of opioid and alcohol use, while disruption of the AI has led to spontaneous loss of cigarette addiction. Although highly effective, DBS is invasive, expensive, and ina…
Eligibility
- Age range
- 21–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Between the ages of 21 and 50 * Nicotine dependent and vape at least 15 mg nicotine per day * Must have a phone with internet access * Participants must have at least a 6th grade education and be able to speak and read English Exclusion Criteria: * History of seizures, seizure disorders, or familial history of seizure disorders * History of intractable migraine or complicated migraine syndromes * History of suicide attempts or active suicidal ideation (past month) * History of cardiac arrhythmias, prolonged QT, pacemakers, or cardiovascular disorders * Hypertension wit…
Interventions
- DeviceTI-NDBS
In the active TI-NDBS condition, participants receive transcranial stimulation for 60 minutes through scalp electrodes using temporal interference (TI). Two electrode sets deliver high-frequency alternating currents (e.g., 2000 Hz and 2020 Hz), generating a 20 Hz beat frequency at depth to stimulate targeted brain regions. Stimulation is delivered in six 10-minute blocks with 30-second ramp-up and ramp-down periods to minimize discomfort. Electrode configurations differ by group to target either the nucleus accumbens or anterior insula, based on finite element modeling. The maximum current is up to 2 mA per electrode, and no single region receives more than 2 mA.
- DeviceSham TI-NDBS
This is the control condition in which participants will receive sham stimulation for 60 minutes.
Location
- Indiana UniversityBloomington, Indiana