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.
12345Is 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.
15678How 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.
124910Eligibility 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.
+7 more
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.
+11 more
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
Participant Groups
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.
3Treatment groups
Active Control
Placebo Group
Group I: 1Hz ArmActive Control1 Intervention
ThorS-MagNT treatment intervention with 2400 total stimulations at 1Hz with the magnetic coil.
Group II: 10Hz ArmActive Control1 Intervention
ThorS-MagNT treatment intervention with 2400 total stimulations at 10Hz with the magnetic coil.
Group III: Sham ArmPlacebo Group1 Intervention
Sham intervention with 2400 total sham stimulations with the magnetic coil.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Augusta UniversityAugusta, GA
Loading ...
Who Is Running the Clinical Trial?
Augusta UniversityLead Sponsor
References
[Clinical and neurological evaluation of the efficiency of transspinal magnetic stimulation during surgical treatment of tuberculosis spondylitis]. [2019]The clinical and neurophysiological efficiency of high-intensity transpinal rhythmic magnetic stimulation was studied during surgical treatment in patients with tuberculosis spondylitis complicated by neurological disorders. Its highest efficiency was determined in patients with minor neurological disorders, radicular syndrome, and paresis. Magnetic stimulation was shown to affect the regression of neurological symptoms. The use of electric neuromyography allows quantitative assessment of the course of reparative processes in the pathways.
[Role of transcranial magnetic stimulation in the diagnosis of cervical root compression and cervical myelopathy]. [2006]We were interested in the question, if transcranial magnetic stimulation of nerve structure can be used in the objective description of motor impairment in humans with cervical nerve root compression and myelopathies. We could demonstrate, that paresis is combined with an increase of the latency of the evoked muscle potentials. Applications of the method in Orthopaedics and Neurosurgery involve description of motor deficits in cervical compression radiculopathy and myelopathy. Although the value of the method for orthopaedic and neurosurgical purposes is not yet clear, our experiences indicate interesting diagnostic possibilities in cervical spine diagnostics.
Clinical evaluation of magnetic stimulation in cervical spondylosis. [2019]Conduction in central motor pathways and motor roots was assessed, using the new technique of magnetic stimulation, in 39 patients with cervical spondylosis. Recordings were taken from abductor digiti minimi in all patients and from biceps brachii and abductor hallucis in some. Findings were abnormal ipsilaterally in 27 out of 63 muscles examined in patients with myelopathy, and in 2 out of 38 muscles in patients with radiculopathy. No abnormality was found in 11 muscles examined in patients with negative radiology. There was some correlation between the degree of electrophysiological change and clinical disability. Abnormal conduction was found in some patients with cord compression at the C3/4 or C4/5 interspace but not in a small group with compression at the C5/6 interspace. It seems that magnetic stimulation will provide objective confirmation of upper motor neurone involvement and may provide some measure of its degree, but at present it does not appear to be superior to clinical methods in diagnosing its presence. It may also aid the selection of the correct level for surgical decompression.
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]To explore the value of multi-mode neuroelectrophysiological monitoring (MIOM) in evaluating spinal cord and nerve root function in the treatment of thoracic tuberculosis via costal transverse process approach.
Study of central and peripheral conductions to the diaphragm in 22 patients with definite multiple sclerosis. [2006]Involvement of the diaphragm was evaluated electrophysiologically in 22 patients with definite multiple sclerosis. Magnetic transcranial stimulation (MTS), magnetic cervical stimulation at C4 level (MCS) and electric stimulation of the phrenic nerve at the neck (EPS) were performed for measuring latencies, motor conduction times and amplitudes of the responses recorded with a pair of surface or subcutaneous electrodes located at the xiphoid and the 8th costal interspace on the anterior axillary line. Latency of the motor evoked potentials (MEPs) was abnormal: in 9 patients following MTS, in 6 following MCS, in 2 following EPS. The motor conduction time between the cortex and the cervical spine, we called CMCT1, was abnormal in 11 patients and the motor conduction time between the cortex and the neck, we called CMCT2, was abnormal in 8 patients. However CMCT1 was more often unmeasurable than CMCT2 because the MEPs following MCS were unreliable in 4 patients. The conduction time between the cervical spine and the neck was abnormally long in 2 patients but it was paradoxically abnormally short in 3, probably because of the difficulties in locating exactly the place of the stimulation at the cervical C4 level. The MEP amplitude was not considered a reliable parameter because of the large range of the values in our controls, although the mean amplitude was significantly lower in the patients than in the controls. The amplitude of the compound muscle action potential (CMAP) following EPS was below the lower limit of the normal in 9 patients. The percentage of abnormal MEP latencies and CMCTs when both sides were combined was higher for the hemidiaphragms than for the upper limbs and was roughly the same for the hemidiaphragms and the lower limbs. Moreover electrophysiological study of the diaphragm was abnormal in 5 patients without pulmonary symptoms and with normal pulmonary function tests, demonstrating that this study is useful for revealing infraclinical demyelinating lesions on the central motor pathways down to diaphragm. In addition, alterations of the CMAPs in some patients suggest a possible extension of the lesions towards the anterior horns and anterior roots.
Comparison of magnetic and electrical phrenic nerve stimulation in assessment of phrenic nerve conduction time. [2017]Cervical magnetic stimulation (CMS), a nonvolitional test of diaphragm function, is an easy means for measuring the latency of the diaphragm motor response to phrenic nerve stimulation, namely, phrenic nerve conduction time (PNCT). In this application, CMS has some practical advantages over electrical stimulation of the phrenic nerve in the neck (ES). Although normal ES-PNCTs have been consistently reported between 7 and 8 ms, data are less homogeneous for CMS-PNCTs, with some reports suggesting lower values. This study systematically compares ES- and CMS-PNCTs for the same subjects. Surface recordings of diaphragmatic electromyographic activity were obtained for seven healthy volunteers during ES and CMS of varying intensities. On average, ES-PNCTs amounted to 6.41 +/- 0.84 ms and were little influenced by stimulation intensity. With CMS, PNCTs were significantly lower (average difference 1.05 ms), showing a marked increase as CMS intensity lessened. ES and CMS values became comparable for a CMS intensity 65% of the maximal possible intensity of 2.5 Tesla. These findings may be the result of phrenic nerve depolarization occurring more distally than expected with CMS, which may have clinical implications regarding the diagnosis and follow-up of phrenic nerve lesions.
Diaphragm compound muscle action potential measured with magnetic stimulation and chest wall surface electrodes. [2019]To seek a method to reliably measure phrenic nerve conduction time (PNCT) with magnetic stimulation we investigated two stimulus sites, placing the magnetic coil at the cricoid cartilage (high position) or close to the clavicle (low position). We also compared compound muscle action potential (CMAP) recorded from three different sites: in the sixth to eighth intercostal spaces in the anterior axillary line (Ant-a); in the 8th intercostal space close to the midclavicular line; and with one electrode at the lower sternum and the other at the costal margin. Fourteen normal subjects were studied. The PNCT measured by magnetic stimulation in the high position recorded from (Ant-a) was 7.6+/-0.6 on the left side and 8.4+/-0.7 on the right. The PNCT recorded from all three sites become much shorter when the magnetic coil was moved from the high to the low position. Our results show that PNCT can be accurately measured with magnetic stimulation when care is taken to avoid coactivation of the brachial plexus.
Bilateral magnetic stimulation of the phrenic nerves from an anterolateral approach. [2015]We investigated whether bilateral magnetic stimulation of the phrenic nerves from an anterolateral approach (BAMPS) could combine the reproducibility and ease of use of cervical magnetic stimulation (CMS) with the specificity of bilateral electrical stimulation (BES) and whether it could be used in supine subjects. We placed two double 43-mm coils over the phrenic nerves in the neck. BAMPS produced supramaximal phrenic stimulation by electromyogram (EMG) assessment in six of seven subjects. There was no significant difference in the twitch gastric pressure/twitch esophageal pressure ratio (twitch Pgas/Pes) between BAMPS (1.2) and BES (1.3). Both differed from CMS (0.9, p
Transcutaneous magnetic stimulation of descending tracts in the cervical spinal cord in humans. [2019]Percutaneous magnetic stimulation in humans allows non-invasive stimulation of deeply situated nervous structures with little, if any, discomfort and has proven its utility for brain stimulation. At the level of the vertebral canal, magnetic stimulation readily elicits muscle responses through activation of the motor spinal roots, but there has been no evidence for direct stimulation of the spinal cord itself. The present results document the feasibility of directly stimulating descending systems of the cervical spinal cord which synaptically activate motoneurones. A working hypothesis is that the structure thus stimulated may be cortico-motoneuronal pyramidal axons or the propriospinal system.
Cervical magnetic stimulation: the role of the neural foramen. [2019]Magnetic stimulation of cervical nerve roots is a promising new technique, limited in part by uncertainty about the site of nerve depolarization. We used a modified "butterfly" stimulus coil with an easily defined excitation field to activate the C-8/T-1 nerve roots, recording over abductor digiti minimi. Locating both the lowest threshold for stimulation and the points of maximum stimulation, we determined the optimum rostral-caudal position and orientation for the stimulus coil over the posterior neck and upper trunk. The most favorable positions corresponded to the C-8/T-1 neural foramina, and the most favorable orientations to the roots within them. Additional measurements of depth and electric field suggested that the stimuli used should have been insufficient to activate nervous tissue in a homogeneous medium. A simple model indicates that the induced current is intensified where it passes through a bony foramen and explains preferential excitation of the nerve root at this site.