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TMS_AUD+mTBINCT03995173

Pilot rTMS for AUD+mTBI

StatusTerminated
PhasePhase 2
Primary completion
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Record History

All 14 versions: 11 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Stopped Trial terminated Sponsor's reason: COVID and funding Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 1 → 2 participants
    • Results posted: Oct 30, 2026
    • Primary completion date changed from estimate of Mar 31, 2026 to Mar 31, 2020
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints expanded, about 4 words
  2. Minor Primary and study completion dates: Nov 28, 2025 to Mar 31, 2026v12
  3. Notable Primary and study completion dates: Nov 22, 2024 to Nov 28, 2025v11
  4. Notable Primary and study completion dates: Nov 30, 2023 to Nov 22, 2024v10
  5. Minor Site details revisedv9
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary and study completion dates: Nov 30, 2022 to Nov 30, 2023v7
  2. Notable Enrollment target: estimated 20 to confirmed 1
    • Primary and study completion dates: Nov 1, 2021 to Nov 30, 2022
    v6
  3. Notable Primary and study completion dates: Nov 1, 2020 to Nov 1, 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  4. Notable Primary and study completion dates: Apr 30, 2020 to Nov 1, 2020v3
  5. Minor Site contact updatedv2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Total Adverse Event Frequency
Timeframe: immediately after last/10th rTMS session - up to 2 weeks
Total rTMS Sessions Completed
Timeframe: after the 10th and last rTMS treatment session - up to 2 weeks

Secondary (1)

Penn Alcohol Craving Scale

Arms and interventions

activeActive comparator

active rTMS

placeboPlacebo comparator

placebo rTMS

Devices: repetitive transcranial magnetic stimulation

Sites

1 site in 1 country

  • Edward Hines Jr. VA Hospital, Hines, ILHines, Illinois, United States