Deep TMS of Neural Circuits Associated With Stimulant Use Disorder

NCT06578429 | Recruiting FDA Device

• 1 other identifier: 72401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of deep transcranial magnetic stimulation (dTMS) as a treatment for Veterans with a methamphetamine use disorder (MUD).

Conditions

Methamphetamine Use Disorder; Transcranial Magnetic Stimulation

Keywords

Veterans; Deep Transcranial Magnetic Stimulation (dTMS); Neuroimaging; Relapse

Outcome Measures

Primary Outcomes (2)

• Insula Function

  The primary measure of SN function will include insula activation during the monetary incentive delay task, anticipation of loss contrasted with no loss

  1-4 days post-treatment

• Percentage of Days Abstinent

  Methamphetamine use outcomes will be assessed using the TimeLine Follow Back (TLFB) Method, which utilizes calendar cue to recall recent, self-reported substance use, combined with objective biomarker data

  3 months post-treatment

Secondary Outcomes (3)

• Other Salience Network Function

  1-4 days post-treatment

• Resting-State Salience Network

  1-4 days post-treatment

• Binary Relapse

  3 months post-treatment

Study Arms (2)

Active dTMS

EXPERIMENTAL

Participants will receive 30 active dTMS treatments, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.

Device: Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active

Sham dTMS

SHAM COMPARATOR

Participants will receive 30 sham dTMS sessions, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.

Device: Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham

Interventions

Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active DEVICE

The study will utilize the H4 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the bilateral insula, a core salience network node.

Active dTMS

Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham DEVICE

The study will utilize an identical protocol using the H4 coil to administer a sham condition.

Sham dTMS

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be within the age range of 25-75.
• Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate to severe MUD (≥4 diagnostic symptoms).
• Participants must be able to obtain a Motor Threshold (MT), which will be determined during the screening process.
• Participants must have an adequately stable condition and environment to enable attendance at scheduled clinic visits.
• Participants must be able to read, verbalize, understand, and voluntarily sign the Informed Consent Form prior to participation in study procedures in English.
• If participants are on a medication regimen for comorbid symptoms, that regimen will be stable for the duration of the study and patient will be willing to remain on this regimen during the treatment phase.
• Participants must be fluent in English

You may not qualify if:

• Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, ferromagnetic metal in the head and body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/object in the head and body within 30 cm of the treatment coil.
• General medical condition, disease, or neurological disorder that interferes with the assessments or participation.
• Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
• Current substance abuse as determined by positive toxicology screen
• Have a mass lesion, cerebral infarct, or other active CNS disease, including a seizure disorder.
• A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
• Severe impediment to vision, hearing and/or hand movement, as this is likely to interfere with the ability to follow study protocols.
• Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
• Taking benzodiazepines or neuroleptic medications, or any medication known to alter seizure threshold.
• Acute or unstable chronic illness.
• Current or lifetime history of bipolar disorder or psychosis.
• Participation in another concurrent intervention-based clinical trial.

Sponsors & Collaborators

• Stanford University: lead
• VA Palo Alto Health Care System: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (4)

• Koob GF, Volkow ND. Neurocircuitry of addiction. Neuropsychopharmacology. 2010 Jan;35(1):217-38. doi: 10.1038/npp.2009.110.

  PMID: 19710631 BACKGROUND

• Peters SK, Dunlop K, Downar J. Cortico-Striatal-Thalamic Loop Circuits of the Salience Network: A Central Pathway in Psychiatric Disease and Treatment. Front Syst Neurosci. 2016 Dec 27;10:104. doi: 10.3389/fnsys.2016.00104. eCollection 2016.

  PMID: 28082874 BACKGROUND

• Harel M, Perini I, Kampe R, Alyagon U, Shalev H, Besser I, Sommer WH, Heilig M, Zangen A. Repetitive Transcranial Magnetic Stimulation in Alcohol Dependence: A Randomized, Double-Blind, Sham-Controlled Proof-of-Concept Trial Targeting the Medial Prefrontal and Anterior Cingulate Cortices. Biol Psychiatry. 2022 Jun 15;91(12):1061-1069. doi: 10.1016/j.biopsych.2021.11.020. Epub 2021 Dec 6.

  PMID: 35067356 BACKGROUND

• Gay A, Cabe J, De Chazeron I, Lambert C, Defour M, Bhoowabul V, Charpeaud T, Tremey A, Llorca PM, Pereira B, Brousse G. Repetitive Transcranial Magnetic Stimulation (rTMS) as a Promising Treatment for Craving in Stimulant Drugs and Behavioral Addiction: A Meta-Analysis. J Clin Med. 2022 Jan 26;11(3):624. doi: 10.3390/jcm11030624.

  PMID: 35160085 BACKGROUND

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia B Padula, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Michelle R Madore, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Ward, BS

CONTACT

650-493-5000; samward@stanford.edu

Eileen G Fischer, BS

CONTACT

210-993-2065; grace.fischer@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be completed and stored with staff in the Biostatistic Core. Treatment assignments will be recorded on a USB drive read by the device in order to ensure treaters and study investigators remain blinded. In the instance that a serious adverse event (SAE) occur, consultation with the Data Safety and Monitoring Board and the Institutional Review Board will occur to determine the appropriateness of breaking the blind. The blind may be broken for a specific individual in order to determine whether the SAE is related to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, double-blind, sham-controlled

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: March 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Three to twelve months after publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)