Skip to content
DataLookout
Start free
Menu

VNS mTBINCT04437498

Vagal Nerve Stimulation in mTBI

StatusCompleted
PhaseNot applicable
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 15 versions: 12 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 7 more changesShow less
    • Final enrollment: 28 participants (planned 100)
    • Primary completion date changed from estimate of Dec 10, 2026 to Jul 1, 2026
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Primary endpoints revised (5)
    • Study description revised
    • Site details revised
  2. Primary and study completion dates pushed to Dec 10, 2026
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contact updated
    v13
  3. Primary completion date: Sep 20, 2025 to May 21, 2026
    • Site contact updated
    v12
  4. Study completion date: Jan 15, 2026 to Jul 9, 2026v11
  5. Site contact updatedv10
Show 6 earlier versionsHide 6 earlier versions
  1. Phase: Phase 4 to Not applicablev8
  2. Primary completion date: Sep 20, 2024 to Sep 20, 2025
    • Study completion date: Jan 15, 2025 to Jan 15, 2026
    • Site details revised
    v7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  4. Start date: Jan 5, 2021 to Feb 25, 2021
    • Primary completion date: Jul 9, 2024 to Sep 20, 2024
    • Study completion date: Oct 15, 2024 to Jan 15, 2025
    v4
  5. Start date: Nov 2, 2020 to Jan 5, 2021
    • Primary completion date: Jun 3, 2024 to Jul 9, 2024
    • Study completion date: Sep 3, 2024 to Oct 15, 2024
    • Site contact updated
    v3
  6. Start date: Aug 1, 2020 to Nov 2, 2020
    • Primary completion date: Mar 1, 2024 to Jun 3, 2024
    • Study completion date: Jun 28, 2024 to Sep 3, 2024
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

CAPS
Timeframe: three months
Insula
Timeframe: 10 minutes
HVLT-R % retention
Timeframe: baseline versus three months
Change in IL6 Concentration in Blood with Stress
Timeframe: Baseline to 120 minutes after stress
Hippocampal activation
Timeframe: 10 minutes

Secondary (1)

PPG amplitude

Arms and interventions

nVNSExperimental

non invasive vagal nerve stimulation

shamSham comparator

sham stimulation

Devices: sham stimulation, nVNS

Sites

1 site in 1 country

  • Atlanta VA Medical and Rehab Center, Decatur, GADecatur, Georgia, United States