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Cereset Research For Chronic Nausea

NCT05229107 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-03-12

No results posted yet for this study

Summary

This study will explore the use of Cereset Research for symptoms associated with refractory chronic nausea in patients with gastroparesis (GP) in a randomized, clinical trial.

Conditions

Interventions

DEVICE

Cereset Research

Device: Cereset Research The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.

Sponsors & Collaborators

  • The Susanne Marcus Collins Foundation, Inc.

    collaborator OTHER

  • Gastroenterology Project

    collaborator UNKNOWN

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Charles Tegeler, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2024-03-07
Completion
2024-03-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229107 on ClinicalTrials.gov