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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
TNM-DGp Trial 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.Check my eligibility
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.See study design
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.
TNM-DGp 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 have been on the same medication doses for 30 days, except for certain drugs, and agree not to change them during the study.
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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.
TNM-DGp Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Responder rate
Secondary outcome measures
Quality of life (QOL)
TNM-DGp 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
211 Previous Clinical Trials
85,020 Total Patients Enrolled
1 Trials studying Gastroparesis
12 Patients Enrolled for Gastroparesis
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to take part in this research initiative?
"This study has 48 places for outpatients, aged 18-85, with gastroparesis and refractory symptoms. Other criteria include: no known mucosal diseases; fluency in English (as self-reported); and having been on a consistent dose of any medications (excluding psychotropic drugs or opioids) within the previous 30 days - without changes during the trial duration."
Answered by AI
To what extent is participation in this research opportunity being limited?
"Affirmative. According to clinicaltrials.gov, the research is open for enrollment and has been since its initial posting on June 27th 2022; it was last edited two days later on June 29th. Currently, 48 patients are required across a single site."
Answered by AI
Is this research presently open to enrollment?
"Indeed, the current information hosted on clinicaltrials.gov reveals that recruitment for this medical trial is still ongoing; the study was initially posted on June 27th 2022 and last updated two days later. This research requires 48 individuals from 1 location to take part in it."
Answered by AI
Does this experiment have any age restrictions for participating participants?
"This medical experiment has strict age criteria with a lower limit of 18 years old and an upper bound of 85."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
65+
What site did they apply to?
Augusta University
What portion of applicants met pre-screening criteria?
Met criteria
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