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Cereset for Gastroparesis
N/A
Waitlist Available
Led By Charles Tegeler, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with chronic drug- refractory, nausea and vomiting (ages 18 and up)
Stable gastrointestinal symptoms with total GCSI score of greater than or equal to 21
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to v3 (8-10 weeks following completion of the intervention for ei; baseline to v3 (8-10 weeks following completion of the intervention for ei; baseline to v5 (8-10 weeks following completion of the intervention for di)
Awards & highlights
Study Summary
This trial will study whether using Cereset Research can help ease symptoms of chronic nausea in patients with gastroparesis who haven't responded to other treatments.
Who is the study for?
This trial is for adults with chronic nausea and vomiting due to gastroparesis, who have not responded well to drugs. They should have a specific score on the GCSI, confirmed gastric emptying status, and meet Rome-IV criteria. Participants must be able to follow instructions, sit still during sessions, and commit to study procedures. Exclusions include other GI disorders that could explain symptoms, significant liver injury or comorbid conditions like heart disease or malignancy.Check my eligibility
What is being tested?
The Cereset Research intervention is being tested in this study for its effectiveness in treating refractory chronic nausea in patients with gastroparesis. The trial randomly assigns participants to receive either the Cereset treatment or a control condition.See study design
What are the potential side effects?
While specific side effects of Cereset are not detailed here, it's important for participants to note any discomforts such as difficulty sitting still for long periods or using earbuds required by the therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with ongoing nausea and vomiting that doesn't improve with medication.
Select...
My stomach issues have been stable, and my symptom score is 21 or higher.
Select...
I am 18 or older with ongoing nausea and vomiting that doesn't improve with medication.
Select...
I can follow simple instructions and sit still comfortably.
Select...
I am 18 or older with ongoing severe nausea and vomiting that doesn't improve with medication.
Select...
My stomach issues have been stable, and my symptom score is 21 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to v3 (8-10 weeks following completion of the intervention for ei; baseline to v3 (8-10 weeks following completion of the intervention for ei; baseline to v5 (8-10 weeks following completion of the intervention for di)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to v3 (8-10 weeks following completion of the intervention for ei; baseline to v3 (8-10 weeks following completion of the intervention for ei; baseline to v5 (8-10 weeks following completion of the intervention for di)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Gastroparesis Cardinal Symptom Index (GCSI) scores
Change in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGY-SYM) scores
Secondary outcome measures
Change in Center for Epidemiologic Studies Depression Scale (CES-D) scores
Change in Generalized Anxiety Disorder-7 (GAD-7) scores
Change in Nausea Profile (NP) scores
Other outcome measures
Body Weight Changes
Change in Fatigue Severity Scale (FSS) scores
Change in Heart Rate (HR)
+10 moreTrial Design
2Treatment groups
Active Control
Group I: Cereset ResearchActive Control1 Intervention
Intervention arm using 6 CR sessions
Group II: Continued Current CareActive Control1 Intervention
Participants will continue their current care.
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,231 Previous Clinical Trials
1,001,813 Total Patients Enrolled
4 Trials studying Vomiting
346 Patients Enrolled for Vomiting
Susanne Marcus Collins FoundationUNKNOWN
Gastroenterology ProjectUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have serious trouble hearing (and will need to use ear buds during the clinical trial).I have previously used HIRREM, BWO, Cereset, or similar brainwave optimization technologies.I use pain medication more than three days a week or take drugs that affect movement.My liver tests (ALT, AST, bilirubin) are not normal.I do not have conditions like IBD, celiac, or liver disease causing my GI symptoms.My weight is over 400 pounds.I am 18 or older with ongoing nausea and vomiting that doesn't improve with medication.I have a history of fainting or sudden drops in blood pressure.I have not had thoughts of suicide in the last 3 months.Tests show that your stomach empties at a normal or slow rate.You are expected to use or are currently using alcohol or drugs for fun.My stomach issues have been stable, and my symptom score is 21 or higher.I cannot attend study visits or sit comfortably for up to 1.5 hours.I haven't used specific brain stimulation or therapy techniques in the last month.I am unable to give consent for medical procedures.I am 18 or older with ongoing nausea and vomiting that doesn't improve with medication.Your doctor will check if you meet the Rome-IV criteria.I have had seizures or a seizure disorder in the last year.I can follow simple instructions and sit still comfortably.You have had a recent test for your stomach and gallbladder that shows everything is normal.I do not have serious heart disease, cancer, or other major health issues.I am 18 or older with ongoing severe nausea and vomiting that doesn't improve with medication.My stomach issues have been stable, and my symptom score is 21 or higher.You have other medical conditions that might be causing your symptoms, according to the researcher.You have a current H. pylori infection.You have a pacemaker.I am currently taking beta blockers.
Research Study Groups:
This trial has the following groups:- Group 1: Cereset Research
- Group 2: Continued Current Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Vomiting Patient Testimony for trial: Trial Name: NCT05229107 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this clinical experiment?
"As per the details on clinicaltrials.gov, this specific research study is not presently enrolling patients. The trial was initially published on December 1st 2022 and most recently updated on September 27th 2022. Unfortunately recruitment has been suspended; however, there are still 850 other medical studies actively looking for participants at present."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Michigan
Mississippi
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
1
What site did they apply to?
Wake Forest Baptist Health
Wake Forest University Health Sciences
Why did patients apply to this trial?
I have intermittent gastroparesis. I'm willing to try anything to stop the nausea and vomiting from Gastroparesis.
PatientReceived 1 prior treatment
Looking for a treatment to mange my Gastroparesis so I can regain 50 pounds I have lost in 2 years. Currently have separate G and J tubes.
PatientReceived 1 prior treatment
I have a terrible quality of life living like this. My condition has gone on undiagnosed for over 3 years now. My doctor tried Reglan but only relieved some symptoms for about an hour or so, so it doesnt work well for me. Now I am not sure what I should do. I am reaching out for help.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
What is the process of this study?
PatientReceived 2+ prior treatments
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