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Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy

A legfontosabb adatok

Ki végzi
University of Utah
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
45 fő, tervezett
Kezdés
2026. dec.
Várható befejezés
2030. dec.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • 4- Week Dual-Target Transcranial Magnetic Stimulation (TMS)
  • Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS)
  • Treatment as Usual (TAU)
A regiszteradat frissítve
2026. november 5.

Ki vehet részt

Életkor
22 év felett
Nem
Csak nők
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 18 feltétel megnézéseKevesebb

Ki vehet részt

  • Women age 22 years and older who are pregnant with a singleton pregnancy
  • >12 weeks and ≤ 34 weeks gestational age at screening
  • Diagnosis of MaUD in the past 12 months
  • Participant must have engaged in perinatal care (through family medicine, Obstetrics/Gynecology, Internal Medicine, etc) during this pregnancy
  • Capacity to consent
  • Capacity to complete all study procedures

Ki nem vehet részt

  • Unable to receive the TMS treatment (e.g. have metal implants, metal device(s) in their head or body, cochlear implants, implanted brain stimulators, aneurysm clips). Dental implants that are TMS safe are not exclusionary)
  • Lifetime diagnosis of schizophrenia, bipolar disorder, schizoaffective disorder, or psychosis
  • Using any medication that significantly increases the risk of seizure by lowering seizure threshold (for example Wellbutrin over 300 mg daily) or antipsychotics
  • History of epilepsy, a personal history of seizures, or a family history of epilepsy or seizure in a first degree relative
  • History of intracranial hemorrhage, stroke in the past 12 months, intracranial mass, or head trauma in the past 12 months
  • History of or current diagnosis of chronic hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), and/or history of or current diagnosis of preeclampsia
  • Moderate to severe heart disease
  • Any medical condition that in the PI's opinion will interfere with the study or increase risk to the participant
  • Actively suicidal or homicidal
  • Active heavy alcohol use
  • Current participation in another clinical trial (excluding large population-based or observational studies like All of Us)
  • Not able to complete the protocol due to travel, work, etc

A vizsgálatról

Mit akar kideríteni a vizsgálat

The goal of this clinical trial is to learn whether transcranial magnetic stimulation, also called TMS, is a practical and acceptable treatment option for methamphetamine use disorder during pregnancy. The study will enroll pregnant women who have methamphetamine use disorder.

A teljes eredeti leírásKevesebb

The main questions it aims to answer are:

1. Can pregnant women with methamphetamine use disorder be successfully enrolled and complete TMS treatment? 2. Is TMS acceptable to pregnant participants, their caregivers or partners, and clinicians involved in their care? 3. Is it feasible to collect maternal and infant health information during pregnancy and after delivery?

Researchers will compare standard 4-week TMS, accelerated 2-week TMS, and treatment as usual to see which approach is more practical and better tolerated during pregnancy.

Participants will:

* Be randomly assigned to receive standard TMS, accelerated TMS, or treatment as usual. * Complete study visits during pregnancy and follow-up visits after treatment. * Complete questionnaires about substance use, cravings, mood, anxiety, sleep, quality of life, and side effects. * Provide urine drug tests and have vital signs and safety assessments completed. * Allow the study team to review pregnancy and infant medical records. * Some participants will complete interviews about their experiences and views of TMS during pregnancy.

A vizsgálat 3 csoportja

  • Standard Dual-Target TMSA vizsgált kezelés

    Participants receive 16 sessions of dual-target transcranial magnetic stimulation (TMS) delivered over 4 weeks. Treatment includes intermittent theta burst stimulation (iTBS) to the dorsolateral prefrontal cortex (DLPFC) followed by continuous theta burst stimulation (cTBS) to the medial prefrontal cortex (mPFC).

    Kezelés: 4- Week Dual-Target Transcranial Magnetic Stimulation (TMS)

  • 2-week Dual-Target TMSA vizsgált kezelés

    Participants will receive dual-target TMS delivered sequentially to the DLPFC and mPFC. Target localization will follow the international 10-20 EEG system using the Beam F3 and FP1 positions, consistent with prior studies. Each session will include iTBS to the DLPFC administered as 2-second trains of 50-Hz triplets delivered at 5 Hz, with an 8-second intertrain interval, totaling 600 pulses, and cTBS to the mPFC consisting of continuous 50-Hz triplets totaling 600 pulses. A total of 16 sessions will be delivered: 3-4 sessions/day (with 30-60 minutes between sessions) delivered on 4-5 treatment days within a 2-week timeframe.

    Kezelés: Accelerated Dual-Target Transcranial Magnetic Stimulation (aTMS)

  • Treatment as UsualMár használt kezelés, összehasonlításként

    Participants continue receiving standard clinical care for methamphetamine use disorder during pregnancy without study-administered TMS.

    Kezelés: Treatment as Usual (TAU)

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Developing Transcranial Magnetic Stimulation as a Therapeutic Modality for Methamphetamine Use Disorder During Pregnancy
A regiszteradat frissítve
2026. november 5.