Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05273788 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Thoracic Neuromodulation for Diabetic Gastroparesis

Study acronym: TNM-DGp
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Phase changed: Phase 1 → not applicable · Results posted: Sep 14, 2026 · Trial completed · 4 morev8 Show 7 more changesShow less
    • Phase changed: Phase 1 → not applicable
    • Results posted: Sep 14, 2026
    • Trial completed
    • Final enrollment: 36 participants (planned 48)
    • Primary completion moved earlier from May 31, 2026 to Jun 30, 2025
    • Study completion date changed from estimate of May 31, 2027 to Jun 30, 2026
    • Secondary endpoints: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  2. Phase: Phase 1 to Not applicable Primary endpoint revised · Trial status: Active, Not Recruiting to Completed · Enrollment target: estimated 48 to confirmed 36 · 3 morev7 Show 6 more changesShow less
    • Primary endpoint revised
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 48 to confirmed 36
    • Primary completion date: May 31, 2026 to Jun 30, 2025
    • Study completion date changed from estimate of May 31, 2027 to Jun 30, 2026
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Completion date: May 31, 2026 to May 31, 2027 · Site details revisedv6 Show 2 more changesShow less
    • Completion date: May 31, 2026 to May 31, 2027
    • Site details revised
  4. Lead sponsor: Augusta University to Medical University of South Carolina Primary and study completion dates: May 31, 2025 to May 31, 2026 · Collaborators expanded, about 15 wordsv5 Show 2 more changesShow less
    • Primary and study completion dates: May 31, 2025 to May 31, 2026
    • Collaborators expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  5. Phase: Not applicable to Phase 1 Start date: Jun 27, 2022 to Jul 27, 2022 · Primary completion date: Jan 31, 2025 to May 31, 2025 · Completion date: Mar 30, 2025 to May 31, 2025 · 1 morev4 Show 4 more changesShow less
    • Start date: Jun 27, 2022 to Jul 27, 2022
    • Primary completion date: Jan 31, 2025 to May 31, 2025
    • Completion date: Mar 30, 2025 to May 31, 2025
    • Site contact updated
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 1, 2022 to Jun 27, 2022 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Apr 1, 2022 to Jun 27, 2022
    • Site details revised
  2. Secondary endpoints: details revised at 1 of 1 entry Study description expanded, about 21 wordsv2 Show 1 more changeShow less
    • Study description expanded, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The global incidence of diabetes is rising. Gastroparesis is a significant complication of diabetes that results in debilitating symptoms and affects quality of life. Current treatment options for diabetic gastroparesis are limited. Significant visceral afferent neuropathy is associated with diabetic gastroparesis and sympathetic overactivity is seen in nausea, both type 1 and 2 diabetes, and diabetic complications. These dysfunctions can result from neuropathy affecting the thoracic spinal nerves that carry both general visceral afferents and preganglionic sympathetic efferents in the greater splanchnic nerve, innervating the foregut. Neuromodulation of the thoracic spinal nerves should improve diabetic gastroparesis symptoms and restore quality of life by improving neuropathy and gastric sensori-motor function. The investigators has developed and refined a novel, noninvasive, neuromodulation treatment, Thoracic Spinal Nerve Magnetic Neuromodulation Therapy (ThorS-MagNT). In an uncontrolled trial of adults with diabetic gastroparesis, ThorS-MagNT the investigators demonstrated feasibility, acceptability, and improvement of DGp symptoms. Whether active neuromodulation is better than sham therapy and the optimal frequency of treatment are not known. The investigators propose to conduct a dose-ranging, sham-controlled trial (pilot NIH Stage 1b) to assess the effect of ThorS-MagNT on symptom severity and quality of life in diabetic gastroparesis (TNM-DGp Trial). The investigators will test the hypothesis that ThorS-MagNT will improve visceral afferent neuropathy, autonomic and gastric dysfunction, compared to sham. The investigators will also test whether any improvements are due to neuromodulation of (a) peripheral spino-gut axis or (b) central structures of the limbic system and autonomic network, or both. Successful completion of this pilot study will provide insights into gastroparesis disease processes and inform mechanisms of action of neuromodulation therapy in addressing disruption of the brain-gut axis. Expected outcomes include development of a novel, non-invasive, safe and efficacious therapy for diabetic gastroparesis. These efforts will inform future true efficacy testing in an NIH Stage 2 trial using multiphase optimization strategy (MOST) design.
Trial Details
NCT Number NCT05273788
Lead Sponsor Medical University of South Carolina
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Conditions Diabetic Gastroparesis
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov