Neuromodulation for Gastroparesis

(TNM-DGp Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Augusta University

Must not be taking: Psychotropic, Opioids, Illicit drugs

Disqualifiers: Postsurgical gastroparesis, Gastrointestinal obstruction, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment ThorS-MagNT for gastroparesis?

The research on magnetic stimulation shows it can help improve neurological symptoms in conditions like tuberculosis spondylitis and cervical spondylosis, suggesting it might also be beneficial for gastroparesis by potentially improving nerve function. ^{1 2 3 4 5}

Is magnetic stimulation safe for humans?

The research on magnetic stimulation, including studies on phrenic nerve and diaphragm function, suggests it is generally safe for humans, with no significant adverse effects reported in healthy volunteers or patients with conditions like multiple sclerosis and tuberculosis spondylitis. ^{1 5 6 7 8}

How is the treatment ThorS-MagNT different from other treatments for gastroparesis?

ThorS-MagNT is unique because it uses magnetic stimulation to target the thoracic spinal nerves, which is a non-invasive approach that may help improve nerve function and reduce symptoms. This method is different from traditional treatments that often involve medications or dietary changes, as it directly influences nerve pathways to potentially enhance gastrointestinal motility. ^{1 2 4 9 10}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Sham Stimulations (Behavioural Intervention)
• ThorS-MagNT (Neuromodulation)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Augusta University Augusta, GA

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Patients Recruited

85,900+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical and neurological evaluation of the efficiency of transspinal magnetic stimulation during surgical treatment of tuberculosis spondylitis]. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Role of transcranial magnetic stimulation in the diagnosis of cervical root compression and cervical myelopathy]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of magnetic stimulation in cervical spondylosis. [2019]

4. Australia 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. [2021]

5. Belgium pubmed.ncbi.nlm.nih.gov

Study of central and peripheral conductions to the diaphragm in 22 patients with definite multiple sclerosis. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of magnetic and electrical phrenic nerve stimulation in assessment of phrenic nerve conduction time. [2017]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Diaphragm compound muscle action potential measured with magnetic stimulation and chest wall surface electrodes. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Bilateral magnetic stimulation of the phrenic nerves from an anterolateral approach. [2015]

9. Ireland pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Cervical magnetic stimulation: the role of the neural foramen. [2019]