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Neuromodulation
Neuromodulation for Gastroparesis (TNM-DGp Trial)
N/A
Recruiting
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No known mucosal disease
Men or women age less than 85
Must not have
Prior gastric surgery (fundoplication, gastric resection or pyloroplasty)
Enteral or parenteral feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Summary
This trial is testing a new noninvasive treatment for gastroparesis that uses neuromodulation to improve symptoms. The hypothesis is that this new treatment will be better than a sham treatment at improving symptoms.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a noninvasive neuromodulation therapy using magnetic stimulation rather than drugs or surgery, side effects are expected to be minimal. However, specific side effect details will likely be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any known diseases affecting the moist tissues of my body.
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I am younger than 85 years old.
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I am younger than 85 years old.
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I do not have any known diseases affecting the moist linings of my body.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery on my stomach before.
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I am receiving nutrition through a feeding tube or IV.
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I have slow stomach emptying after surgery.
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I am currently taking medication that stimulates my nervous system.
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I do not have severe heart disease or irregular heartbeats.
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I have a history of seizures.
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I have an active inflammatory bowel condition.
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I have a diagnosed digestive disorder and less than one bowel movement every 2 weeks.
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I have a blockage in my digestive tract.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Responder rate
Secondary study objectives
Quality of life (QOL)
Trial Design
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.
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
215 Previous Clinical Trials
85,642 Total Patients Enrolled
1 Trials studying Gastroparesis
12 Patients Enrolled for Gastroparesis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.I am currently taking medication that stimulates my nervous system.I do not have severe heart disease or irregular heartbeats.You are an outpatient with persistent symptoms and a moderate to severe ANMS GCSI-DD score.I have a history of seizures.You have a serious mental illness that needs separate treatment.I have an active inflammatory bowel condition.I haven't changed my dosage of medications like antidepressants or gabapentin in the last 3 months.I have a diagnosed digestive disorder and less than one bowel movement every 2 weeks.People with ongoing digestive symptoms and a high score on a specific symptom scale will not be included.I have been on the same medication doses for 30 days and won't change them during the study.You have metal implants that are not safe for MRI, or devices like gastric electrical stimulators, deep brain stimulators, sacral nerve stimulators, or pacemakers.I am younger than 85 years old.I have a blockage in my digestive tract.I do not have any known diseases affecting the moist linings of my body.You use opioids more than 3 times a week and marijuana more than 5 times a week.
Research Study Groups:
This trial has the following groups:- Group 1: 1Hz Arm
- Group 2: 10Hz Arm
- Group 3: Sham Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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