Diabetic GastroparesisTNM-DGpNCT05273788
Thoracic Neuromodulation for Diabetic Gastroparesis
A study testing 2400 ThorS-MagNT Stimulations at 1Hz and 2400 ThorS-MagNT Stimulations at 10Hz in people with Diabetic Gastroparesis, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- 2400 ThorS-MagNT Stimulations at 1Hz and 2400 ThorS-MagNT Stimulations at 10Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient DGp patients with refractory symptoms and total ANMS GCSI-DD score ≥ 2.0 (moderate-severe severity) during screening period;
- Men or women age less than 85;
- No known mucosal disease;
- Speak, write, and understand English (by self-report);
- On stable doses of any medication for 30 days prior to entering the study (exceptions are psychotropic, opioids, and/or illicit drugs) and agrees not to change medications or dosages during the study period.
Who cannot join
- Postsurgical gastroparesis;
- Gastrointestinal obstruction;
- Prior gastric surgery (fundoplication, gastric resection or pyloroplasty);
- Achalasia, Chronic Intestinal Pseudo-obstruction, Colonic Inertia with one complete spontaneous bowel movement (CSBM) less than every 2 weeks;
- Active inflammatory bowel disease;
- Use of opioids greater than 3 times a week and marijuana more than 5 times a week;
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- Change in neuromodulator dosage in last 3 months (tricyclic antidepressants, gabapentin, olanzapine, etc.);
- Use of sympathomimetics;
- Seizure history or disorder;
- Active serious psychiatric illness that would warrant independent attention;
- Severe, unstable cardiac disease and arrhythmias;
- Metal implants that are not MR safe, gastric electrical stimulators (GES), deep brain stimulators (DBS), sacral nerve stimulators (SNS), or pacemakers;
- Pregnant women or nursing mothers;
- Enteral or parenteral feeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The proposed TNM-DGp trial is a pilot sham-controlled RCT to test the preliminary efficacy of ThorS-MagNT to improve DGp symptom severity and related quality of life. The investigators will also explore mechanisms of change and potential moderators of treatment outcome after ThorS-MagNT. The trial will be conducted over the 3-year pilot RO1.
Randomization: Using the magnitude of change in DGp symptom severity in the initial pilot trial, the investigators will randomize 48 patients in a 1:1:1 ratio to either receive sham, 1 Hz, or 10 Hz ThorS-MagNT over a 5-day period. The investigators will use blocked randomization with a block size ranging from 3 to 6 and known only to the biostatistician. The biostatistician will create the randomization sequence for all participants prior to any pre-treatment assessments. Treatment allocation will be made available to the interventionists only after baseline assessments, determination of eligibility, and informed consent.
Participants (N = 48): The investigators will recruit TNM-DGp trial participants at Augusta University. Approximately 2-3 DGp patients are seen per week at our center. To further facilitate recruitment, advertisements will be put into newsletters of both hospitals, local newspaper, and radio. Flyers will be placed in GI, family medicine, internal medicine, and endocrine clinics, and locoregional colleagues will be emailed. Forty-eight adult, DGp outpatients with refractory symptoms of greater than 6 months and moderate-severe disease (total American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index (ANMS GCSI) score greater than or equal to 2.0) will be recruited. Participants will be screened by phone to assess eligibility and interest in the study. Those who are eligible and interested in the study will complete informed consent.
Sample size justification: Assuming a responder rate of 30% for the sham arm, we consider a 1:1:1 balanced design for the sham, 1 Hz, and 10 Hz treatment arms, respectively. For the primary clinical outcome, the difference is assessed between sham and the combined treatment arm (1 Hz and 10 Hz), giving a 1:2 allocation. A sample size of 14 per treatment arm is required to observe a responder rate of 65% for the combined treatment arm with 80% power at 5% significance level. This sample size is sufficient to observe a 1-point improvement in the PAGI-QOL score (secondary clinical outcome) with 85% power. Accounting for a 15% dropout in the study, the investigators will need 16 subjects per treatment arm. For the proposed interim analysis at 33% and 66% recruitment, the investigators will have enough sample size (5 and 10 per treatment arm respectively) to achieve 80% power if the responder rate in the treatment arms is 90% and 77% respectively.
Clinical outcome (Aim 1) measures: The primary clinical outcome will be responder rate with responder defined as ≥30% improvement in gastroparesis symptom severity by the Week 4 ANMS total GCSI-DD compared to baseline. The total ANMS GCSI-DD score includes a 7-day average of 5 gastroparesis-specific items. A greater than 30% reduction in total symptom score is defined as a responder by the FDA User Manual for the ANMS GSCI-DD. Secondary clinical outcome will be improvement in quality of life, defined by a 1-point improvement in Patient Assessment of Gastrointestinal Symptoms-Quality of Life (PAGI-QOL). ANMS GCSI-DD will be collected monthly for one year after treatment. Duration of response will be defined as time to loss of response (<30% improvement over baseline total ANMS GCSI-DD score).
Exploratory mechanisms of change (Aim 2) assessments: The investigators will evaluate potential mechanisms of change pre- to post-treatment including change in activity levels and functional connectivity to surrounding brain regions of the insula by dipolar source localization and fMRI; sensation by quantitative sensory testing (QST) and satiety test; autonomic function testing; and and gastric emptying breath tests. Exploratory moderators of outcome measures. The investigators will characterize patients at pre-treatment by various clinical variables including: age, gender, type of diabetes (type 1 vs type 2), glycemic control (Hemoglobin A1c (HbA1c)), hip/waist circumference, Body Mass Index (BMI), Gastrointestinal-specific anxiety (Visceral Sensitivity Index; (VSI)), interoceptive awareness (Multidimensional Assessment of Interoceptive Awareness, (MAIA)), Patient-Reported Outcome Measurement Information System (PROMIS), and presence of depression or anxiety (by Hospital Anxiety and Depression Scale; (HADS)). The investigators will explore these characteristics as potential moderators of treatment outcome (associated with change in total ANMS GSCI-DD and outcome questionnaire scores).
- Conditions
- Diabetic Gastroparesis
- Being tested
- 2400 ThorS-MagNT Stimulations at 1Hz, 2400 ThorS-MagNT Stimulations at 10Hz, Sham Stimulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2400 ThorS-MagNT Stimulations at 1HzDevice
The inferior angles of the scapula will serve as landmarks for the T7 level. A mapping procedure is performed with subject in the seated position using a single-pulse stimulation circular 90- mm coil to determine the location and minimum intensity of stimulation left and right of the T7 spinous process required to achieve a motor evoked response (MEP) of 50 μV with 50% of trials (resting motor threshold) in the upper rectus abdominis or external oblique muscles. The intensity for ThorS-MagNT is set at 150% above motor threshold. 1 Hz ThorS-MagNT, one of 4 total trains is delivered over 5 minutes with 3-min rest intervals on both right and left sides (total 1200 pulses/side).
2400 ThorS-MagNT Stimulations at 10HzDevice
The inferior angles of the scapula will serve as landmarks for the T7 level. A mapping procedure is performed with subject in the seated position using a single-pulse stimulation circular 90- mm coil to determine the location and minimum intensity of stimulation left and right of the T7 spinous process required to achieve a motor evoked response (MEP) of 50 μV with 50% of trials (resting motor threshold) in the upper rectus abdominis or external oblique muscles. The intensity for ThorS-MagNT is set at 150% above motor threshold. 10Hz ThorS-MagNT involves delivering one train of 100 pulses per minute with 50-second rest intervals over twelve minutes on both right and left sides (total 1200 pulses/side).
Sham StimulationsDevice
The inferior angles of the scapula will serve as landmarks for the T7 level. A mapping procedure is performed with subject in the seated position using a single-pulse stimulation circular 90- mm coil to determine the location and minimum intensity of stimulation left and right of the T7 spinous process required to achieve a motor evoked response (MEP) of 50 μV with 50% of trials (resting motor threshold) in the upper rectus abdominis or external oblique muscles. The intensity for ThorS-MagNT is set at 150% above motor threshold. Sham stimulations, one of 4 total trains is delivered over 5 minutes with 3-min rest intervals on both right and left sides (total 1200 pulses/side).
| Study group | Role | What they receive |
|---|---|---|
| 1Hz Arm | Active comparator | ThorS-MagNT treatment intervention with 2400 total stimulations at 1Hz with the magnetic coil. Receives: Device: 2400 ThorS-MagNT Stimulations at 1Hz |
| 10Hz Arm | Active comparator | ThorS-MagNT treatment intervention with 2400 total stimulations at 10Hz with the magnetic coil. Receives: Device: 2400 ThorS-MagNT Stimulations at 10Hz |
| Sham Arm | Sham comparator | Sham intervention with 2400 total sham stimulations with the magnetic coil. Receives: Device: Sham Stimulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ANMS GCSI-DD Score
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) total score from Baseline to Week 4. The ANMS GCSI-DD is a patient-reported measure of gastroparesis symptom severity based on 5 gastroparesis-specific symptom items averaged over a 7-day period. Total scores range from 0 to 5, where higher scores indicate more severe gastroparesis symptoms and lower scores indicate less severe symptoms. Difference was calculated as Baseline score minus Week 4 score, such that larger positive values indicate greater improvement in symptoms.
Measured: Baseline and Week 4
Secondary outcomes (1)
Change in PAGI-QOL Score
Change in Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QOL) total score from Baseline to Week 4. PAGI-QOL is a patient-reported measure of quality of life related to upper gastrointestinal disorders. Scores range from 0 to 5, with higher scores indicating better quality of life and lower scores indicating worse quality of life. Change was calculated as Week 4 score minus Baseline score, such that positive values indicate improvement in quality of life.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start27 Jul 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273788
- Sponsor's protocol ID
- 1870454
- Other IDs
- Pro00146242
- Acronym
- TNM-DGp
- Status last verified
- Aug 2026
- First submitted
- 2 Mar 2022
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Neuromodulation for Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT05273788
- Acronym / sponsor ID
- TNM-DGp / 1870454
- Conditions
- Diabetic Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Posted 14 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed TNM-DGp trial is a pilot sham-controlled RCT to test the preliminary efficacy of ThorS-MagNT to improve DGp symptom severity and related quality of life. The investigators will also explore mechanisms of change and potential moderators of treatment outcome after ThorS-MagNT. The trial will be conducted over the 3-year pilot RO1.
Randomization: Using the magnitude of change in DGp symptom severity in the initial pilot trial, the investigators will randomize 48 patients in a 1:1:1 ratio to either receive sham, 1 Hz, or 10 Hz ThorS-MagNT over a 5-day period. The investigators will use blocked randomization with a block size ranging from 3 to 6 and known only to the biostatistician. The biostatistician will create the randomization sequence for all participants prior to any pre-treatment assessments. Treatment allocation will be made available to the interventionists only after baseline assessments, determination of eligibility, and informed consent.
Participants (N = 48): The investigators will recruit TNM-DGp trial participants at Augusta University. Approximately 2-3 DGp patients are seen per week at our center. To further facilitate recruitment, advertisements will be put into newsletters of both hospitals, local newspaper, and radio. Flyers will be placed in GI, family medicine, internal medicine, and endocrine clinics, and locoregional colleagues will be emailed. Forty-eight adult, DGp outpatients with refractory symptoms of greater than 6 months and moderate-severe disease (total American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index (ANMS GCSI) score greater than or equal to 2.0) will be recruited. Participants will be screened by phone to assess eligibility and interest in the study. Those who are eligible and interested in the study will complete informed consent.
Sample size justification: Assuming a responder rate of 30% for the sham arm, we consider a 1:1:1 balanced design for the sham, 1 Hz, and 10 Hz treatment arms, respectively. For the primary clinical outcome, the difference is assessed between sham and the combined treatment arm (1 Hz and 10 Hz), giving a 1:2 allocation. A sample size of 14 per treatment arm is required to observe a responder rate of 65% for the combined treatment arm with 80% power at 5% significance level. This sample size is sufficient to observe a 1-point improvement in the PAGI-QOL score (secondary clinical outcome) with 85% power. Accounting for a 15% dropout in the study, the investigators will need 16 subjects per treatment arm. For the proposed interim analysis at 33% and 66% recruitment, the investigators will have enough sample size (5 and 10 per treatment arm respectively) to achieve 80% power if the responder rate in the treatment arms is 90% and 77% respectively.
Clinical outcome (Aim 1) measures: The primary clinical outcome will be responder rate with responder defined as ≥30% improvement in gastroparesis symptom severity by the Week 4 ANMS total GCSI-DD compared to baseline. The total ANMS GCSI-DD score includes a 7-day average of 5 gastroparesis-specific items. A greater than 30% reduction in total symptom score is defined as a responder by the FDA User Manual for the ANMS GSCI-DD. Secondary clinical outcome will be improvement in quality of life, defined by a 1-point improvement in Patient Assessment of Gastrointestinal Symptoms-Quality of Life (PAGI-QOL). ANMS GCSI-DD will be collected monthly for one year after treatment. Duration of response will be defined as time to loss of response (<30% improvement over baseline total ANMS GCSI-DD score).
Exploratory mechanisms of change (Aim 2) assessments: The investigators will evaluate potential mechanisms of change pre- to post-treatment including change in activity levels and functional connectivity to surrounding brain regions of the insula by dipolar source localization and fMRI; sensation by quantitative sensory testing (QST) and satiety test; autonomic function testing; and and gastric emptying breath tests. Exploratory moderators of outcome measures. The investigators will characterize patients at pre-treatment by various clinical variables including: age, gender, type of diabetes (type 1 vs type 2), glycemic control (Hemoglobin A1c (HbA1c)), hip/waist circumference, Body Mass Index (BMI), Gastrointestinal-specific anxiety (Visceral Sensitivity Index; (VSI)), interoceptive awareness (Multidimensional Assessment of Interoceptive Awareness, (MAIA)), Patient-Reported Outcome Measurement Information System (PROMIS), and presence of depression or anxiety (by Hospital Anxiety and Depression Scale; (HADS)). The investigators will explore these characteristics as potential moderators of treatment outcome (associated with change in total ANMS GSCI-DD and outcome questionnaire scores).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1Hz Arm | Active comparator | Device: 2400 ThorS-MagNT Stimulations at 1HzThorS-MagNT treatment intervention with 2400 total stimulations at 1Hz with the magnetic coil. |
| 10Hz Arm | Active comparator | Device: 2400 ThorS-MagNT Stimulations at 10HzThorS-MagNT treatment intervention with 2400 total stimulations at 10Hz with the magnetic coil. |
| Sham Arm | Sham comparator | Device: Sham StimulationsSham intervention with 2400 total sham stimulations with the magnetic coil. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatient DGp patients with refractory symptoms and total ANMS GCSI-DD score ≥ 2.0 (moderate-severe severity) during screening period;
- Men or women age less than 85;
- No known mucosal disease;
- Speak, write, and understand English (by self-report);
- On stable doses of any medication for 30 days prior to entering the study (exceptions are psychotropic, opioids, and/or illicit drugs) and agrees not to change medications or dosages during the study period.
Key exclusion criteria (14 listed)
- Postsurgical gastroparesis;
- Gastrointestinal obstruction;
- Prior gastric surgery (fundoplication, gastric resection or pyloroplasty);
- Achalasia, Chronic Intestinal Pseudo-obstruction, Colonic Inertia with one complete spontaneous bowel movement (CSBM) less than every 2 weeks;
- Active inflammatory bowel disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2400 ThorS-MagNT Stimulations at 1HzThe inferior angles of the scapula will serve as landmarks for the T7 level. A mapping procedure is performed with subject in the seated position using a single-pulse stimulation circular 90- mm coil to determine the location and minimum intensity of stimulation left and right of the T7 spinous process required to achieve a motor evoked response (MEP) of 50 μV with 50% of trials (resting motor threshold) in the upper rectus abdominis or external oblique muscles. The intensity for ThorS-MagNT is set at 150% above motor threshold. 1 Hz ThorS-MagNT, one of 4 total trains is delivered over 5 minutes with 3-min rest intervals on both right and left sides (total 1200 pulses/side). | Device | 1Hz Arm |
| 2400 ThorS-MagNT Stimulations at 10HzThe inferior angles of the scapula will serve as landmarks for the T7 level. A mapping procedure is performed with subject in the seated position using a single-pulse stimulation circular 90- mm coil to determine the location and minimum intensity of stimulation left and right of the T7 spinous process required to achieve a motor evoked response (MEP) of 50 μV with 50% of trials (resting motor threshold) in the upper rectus abdominis or external oblique muscles. The intensity for ThorS-MagNT is set at 150% above motor threshold. 10Hz ThorS-MagNT involves delivering one train of 100 pulses per minute with 50-second rest intervals over twelve minutes on both right and left sides (total 1200 pulses/side). | Device | 10Hz Arm |
| Sham StimulationsThe inferior angles of the scapula will serve as landmarks for the T7 level. A mapping procedure is performed with subject in the seated position using a single-pulse stimulation circular 90- mm coil to determine the location and minimum intensity of stimulation left and right of the T7 spinous process required to achieve a motor evoked response (MEP) of 50 μV with 50% of trials (resting motor threshold) in the upper rectus abdominis or external oblique muscles. The intensity for ThorS-MagNT is set at 150% above motor threshold. Sham stimulations, one of 4 total trains is delivered over 5 minutes with 3-min rest intervals on both right and left sides (total 1200 pulses/side). | Device | Sham Arm |
Primary outcome
Difference in ANMS GCSI-DD Score
Time frame: Baseline and Week 4
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) total score from Baseline to Week 4. The ANMS GCSI-DD is a patient-reported measure of gastroparesis symptom severity based on 5 gastroparesis-specific symptom items averaged over a 7-day period. Total scores range from 0 to 5, where higher scores indicate more severe gastroparesis symptoms and lower scores indicate less severe symptoms. Difference was calculated as Baseline score minus Week 4 score, such that larger positive values indicate greater improvement in symptoms.
1 secondary outcome
Change in PAGI-QOL Score
Time frame: Baseline and Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2400 ThorS-MagNT Stimulations at 1Hz and 2400 ThorS-MagNT Stimulations at 10Hz in people with Diabetic Gastroparesis, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in ANMS GCSI-DD Score (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.