Neuromodulation for Gastroparesis

(TNM-DGp Trial)

Overseen By Dhanush Shimoga, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical University of South Carolina

Must not be taking: Psychotropic, Opioids, Illicit drugs

Disqualifiers: Postsurgical gastroparesis, Gastrointestinal obstruction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 week

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, Thoracic Spinal Nerve Magnetic Neuromodulation Therapy (ThorS-MagNT), for individuals with diabetic gastroparesis, a condition where the stomach can't empty properly, causing serious digestive issues. The study compares different frequencies of this non-invasive therapy to a placebo (sham stimulations) to determine if it can reduce symptoms and enhance life quality by improving nerve function and digestion. It seeks participants with diabetic gastroparesis who have moderate to severe symptoms and stable medication use. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

You need to be on stable doses of your current medications for at least 30 days before joining the study and agree not to change them during the study. However, if you are taking psychotropic drugs, opioids, or illicit drugs, you may need to stop or adjust those.

What prior data suggests that this neuromodulation technique is safe for treating diabetic gastroparesis?

Studies have shown that ThorS-MagNT, a new noninvasive treatment, can greatly improve symptoms of diabetic gastroparesis. Gastroparesis occurs when the stomach doesn't empty food properly, causing nausea and discomfort. Earlier research found that patients experienced over 60% improvement in key symptoms like nausea and feeling full after meals.

ThorS-MagNT uses magnetic stimulation on the nerves in the upper back, which past studies have shown to be safe. No major side effects were reported, and participants tolerated it well. Although this trial is in its early stages, positive safety results from previous studies suggest that the treatment could be a safe option for those with diabetic gastroparesis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about ThorS-MagNT for gastroparesis because it uses neuromodulation, a novel approach that targets stomach nerves with magnetic stimulation. Unlike standard treatments, which often focus on managing symptoms with medications like antiemetics and prokinetics, ThorS-MagNT aims to directly influence gastric motility by altering nerve activity. This method could offer a more direct and potentially long-lasting solution by addressing the root of the problem rather than just the symptoms. With different stimulation frequencies being tested, there's hope to find the most effective way to improve patient outcomes.

What evidence suggests that ThorS-MagNT could be an effective treatment for diabetic gastroparesis?

Research has shown that Thoracic Spinal Nerve Magnetic Neuromodulation Therapy (ThorS-MagNT), which participants in this trial may receive, may help treat diabetic gastroparesis. In earlier studies, patients experienced more than a 60% improvement in major symptoms like nausea and feeling full after eating small amounts. This therapy uses magnetic pulses to target specific nerves, potentially reducing symptoms and improving quality of life. Although these early results are encouraging, further research is needed to confirm them. Participants in this trial may also receive sham stimulations as part of the study's control group. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults under 85 with diabetic gastroparesis, experiencing moderate to severe symptoms despite treatment. Participants must have been on stable medication doses for 30 days, excluding certain drugs like opioids. It's not open to those with prior gastric surgery, metal implants unsafe for MRI, feeding tubes, recent changes in neuromodulator dosage, pregnant or nursing women, and several other conditions.

Inclusion Criteria

I do not have any known diseases affecting the moist tissues of my body.

I have been on the same medication doses for 30 days, except for certain drugs, and agree not to change them during the study.

I am younger than 85 years old.

Exclusion Criteria

I have had surgery on my stomach before.

I am receiving nutrition through a feeding tube or IV.

I have slow stomach emptying after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive ThorS-MagNT treatment or sham intervention over a 5-day period

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Monthly assessments for one year

Long-term Follow-up

Participants' quality of life and symptom severity are assessed monthly

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Sham Stimulations
• ThorS-MagNT

Trial Overview The study tests a new noninvasive therapy called Thoracic Spinal Nerve Magnetic Neuromodulation (ThorS-MagNT) at different frequencies (1Hz and 10Hz) against sham stimulations. The goal is to see if this can improve symptoms of diabetic gastroparesis by affecting nerve pathways between the spine and gut or brain structures involved in autonomic functions.

How Is the Trial Designed?

Group I: 1Hz Arm Active Control 1 Intervention

ThorS-MagNT treatment intervention with 2400 total stimulations at 1Hz with the magnetic coil.

Group II: 10Hz Arm Active Control 1 Intervention

ThorS-MagNT treatment intervention with 2400 total stimulations at 10Hz with the magnetic coil.

Group III: Sham Arm Placebo Group 1 Intervention

Sham intervention with 2400 total sham stimulations with the magnetic coil.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Transcranial magnetic stimulation can objectively assess motor impairment in patients with cervical nerve root compression and myelopathies, showing that muscle response latency increases with paresis.

This method may offer valuable diagnostic insights for orthopaedic and neurosurgical applications, although its overall clinical utility is still being evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of transcranial magnetic stimulation in the diagnosis of cervical root compression and cervical myelopathy]. Wehling, P., Schulitz, KP., Hartmann, J.[2006]

High-intensity transpinal rhythmic magnetic stimulation is highly effective in treating patients with tuberculosis spondylitis who have minor neurological disorders, radicular syndrome, and paresis, showing significant improvement in neurological symptoms.

The use of electric neuromyography provides a quantitative way to assess the recovery processes in the nervous pathways, enhancing the understanding of treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical and neurological evaluation of the efficiency of transspinal magnetic stimulation during surgical treatment of tuberculosis spondylitis]. Rodnova, IG., Ivanova, TN., Serdobintsev, MS., et al.[2019]

Using a modified 'butterfly' stimulus coil, researchers successfully activated the C-8/T-1 nerve roots, identifying optimal positions and orientations for effective magnetic stimulation over the neck and upper trunk.

The study suggests that the induced current is enhanced when passing through bony foramina, which may explain the preferential excitation of nerve roots at these specific sites, indicating a promising approach for nerve stimulation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical magnetic stimulation: the role of the neural foramen. Epstein, CM., Fernandez-Beer, E., Weissman, JD., et al.[2019]

Phrenic nerve conduction time (PNCT) can be reliably measured using magnetic stimulation, with optimal results obtained when the magnetic coil is placed at the cricoid cartilage (high position) rather than near the clavicle (low position).

In a study of 14 normal subjects, the PNCT was found to be 7.6 ms on the left and 8.4 ms on the right when measured from the anterior axillary line, highlighting the importance of electrode placement to avoid interference from the brachial plexus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diaphragm compound muscle action potential measured with magnetic stimulation and chest wall surface electrodes. Luo, YM., Mustfa, N., Lyall, RA., et al.[2019]

Bilateral magnetic stimulation of the phrenic nerves (BAMPS) effectively stimulates the diaphragm in a way that is comparable to bilateral electrical stimulation (BES), showing high reproducibility and ease of use, especially in supine subjects.

BAMPS demonstrated similar specificity to BES in measuring diaphragm function, with no significant differences in pressure ratios, indicating it could be a reliable alternative for assessing respiratory muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral magnetic stimulation of the phrenic nerves from an anterolateral approach. Mills, GH., Kyroussis, D., Hamnegard, CH., et al.[2015]

The study involved 25 patients with thoracic tuberculosis who underwent surgery using a costal transverse process approach, monitored with multi-mode neuroelectrophysiological techniques to ensure spinal cord and nerve root safety during the procedure.

The use of intraoperative monitoring helped identify and correct abnormalities in nerve function, leading to improved postoperative outcomes, including significant reductions in pain and disability, as well as no reported complications related to nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-modal Neuroelectrophysiological Monitoring in the Treatment of Thoracic Tuberculosis with Debridement and Bone Grafting and Posterior Pedicle Screw Fixation via Costal Transverse Process Approach. Zhang, CW., Shi, SY., Tao, X., et al.[2021]

In a study of 39 patients with cervical spondylosis, magnetic stimulation revealed abnormal conduction in 27 out of 63 muscles in those with myelopathy, indicating significant upper motor neuron involvement.

The technique may help confirm the presence and degree of motor pathway issues, and assist in determining the appropriate surgical intervention level, although it is not yet superior to traditional clinical diagnostic methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of magnetic stimulation in cervical spondylosis. Jaskolski, DJ., Jarratt, JA., Jakubowski, J.[2019]

Cervical magnetic stimulation (CMS) provides a non-invasive method to measure diaphragm function, showing lower phrenic nerve conduction times (PNCT) compared to electrical stimulation (ES), with average CMS-PNCTs being 1.05 ms shorter than ES-PNCTs.

The study found that CMS-PNCTs increased with lower stimulation intensities, suggesting that CMS may depolarize the phrenic nerve more distally, which could impact clinical approaches to diagnosing and monitoring phrenic nerve lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of magnetic and electrical phrenic nerve stimulation in assessment of phrenic nerve conduction time. Similowski, T., Mehiri, S., Duguet, A., et al.[2017]

Percutaneous magnetic stimulation is a non-invasive technique that can effectively stimulate deep nervous structures, including the cervical spinal cord, with minimal discomfort to patients.

This study provides evidence that this method can directly activate descending systems in the spinal cord, potentially involving cortico-motoneuronal pyramidal axons or the propriospinal system, which may enhance muscle response activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous magnetic stimulation of descending tracts in the cervical spinal cord in humans. Tomberg, C.[2019]

In a study of 22 patients with multiple sclerosis, electrophysiological tests revealed abnormal motor evoked potentials (MEPs) in the diaphragm, indicating potential central motor pathway lesions even in patients without respiratory symptoms.

The study found that the diaphragm's motor conduction times were often more affected than those of the upper limbs, suggesting that diaphragm involvement in multiple sclerosis may be more common than previously recognized, highlighting the need for targeted assessments in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of central and peripheral conductions to the diaphragm in 22 patients with definite multiple sclerosis. Lagueny, A., Arnaud, A., Le Masson, G., et al.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030375/

Thoracic Spinal Nerve Neuromodulation Therapy for ... ThorS-MagNT responders had greater than 60.0% improvement in all four gastroparesis cardinal symptom domains (nausea, early satiety, postprandial fullness, and ...

2. cghjournal.org cghjournal.org/article/S1542-3565(22)00910-7/fulltext

Thoracic Spinal Nerve Neuromodulation Therapy for ... ThorS-MagNT responders had greater than 60.0% improvement in all 4 gastroparesis cardinal symptom domains (nausea, early satiety, postprandial ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04706832

Study Details | NCT04706832 | Thoracic Splanchnic ... Specific Aim #1 - Evaluation of the Safety and Effectiveness of Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) in patients with Grade 3 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05273788

Thoracic Neuromodulation for Diabetic Gastroparesis Clinical outcome (Aim 1) measures: The primary clinical outcome will be responder rate with responder defined as ≥30% improvement in gastroparesis symptom ...

5. withpower.com withpower.com/trial/phase-gastroparesis-3-2022-40407

Neuromodulation for Gastroparesis (TNM-DGp Trial) Neuromodulation of the thoracic spinal nerves should improve diabetic gastroparesis symptoms and restore quality of life by improving neuropathy and gastric ...

6. cghjournal.org cghjournal.org/article/S1542-3565(22)00910-7/pdf

Thoracic Spinal Nerve Neuromodulation Therapy for ... Gastric electrical stimulation is approved for compassionate use in refractory patients; however, it is invasive, lacks robust supporting evidence, does not.