Randomized Controlled Study of Optical 3D Navigated Repetitive Transcranial Magnetic Stimulation for Achalasia.

Launched by ZHANG NINA · Sep 6, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for achalasia, a condition that affects the esophagus and makes it difficult for food to pass into the stomach. The treatment being studied is called repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate specific areas of the brain. The goal is to see if this non-invasive method can improve symptoms and quality of life for patients with achalasia. Participants will be randomly assigned to different groups to receive either real or sham (fake) stimulation, and their progress will be monitored through various tests and follow-ups over 12 weeks.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of achalasia. They should be willing to sign a consent form to participate. However, certain individuals, such as those with metal implants in their bodies or specific health conditions, may not be able to join. Throughout the study, participants can expect to undergo assessments of their symptoms and quality of life, and they will receive either real treatment or a placebo to compare the effects. This trial aims to find a safe and effective new approach to managing achalasia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged more than 18 years old, less than 75 years old;
• • Clinical symptoms evaluation, HREM, esophageal barium meal examination confirmed the diagnosis of achalasia;
• • Willing to sign informed consent.
• Exclusion Criteria:
• • Presence of metal hardware in close contact with the discharge coil (e.g., cochlear implant, internal pulse generator, or drug pump). Note: Cochlear implants include electrodes, magnets, loop antennas, and electronic chips under the scalp implanted in the cochlea;
• • Intracranial metal implants;
• • Patients with cardiac pacemakers, vagal nerve stimulation (VNS) systems, spinal cord stimulators, and deep brain stimulation implanted with pulse generators should be used with caution;
• • People at higher risk of noisy hearing loss and patients with hypoacusis symptoms should be used with caution;
• • Pregnancy;
• • Severe or recent heart disease;
• • Personal history of epilepsy, use of known drugs that lower the seizure threshold, and other factors that may lower the seizure threshold (e.g., lack of sleep, infection, and alcohol abuse);
• • Increased intracranial pressure;
• • Acute phase of intracranial infection and hemorrhagic disease;
• • Contraindications to MRI examination or claustrophobia;
• • Refusal to sign informed consent.