Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Zhang Nina

Conditions:

Esophageal Achalasia

Transcranial Magnetic Stimulation, Repetitive

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

The goal of this clinical trial is to investigate the clinical efficacy of repetitive transcranial magnetic stimulation in the treatment of achalasia in patients diagnosed with achalasia by comprehens...

Detailed Description

Study hypothesis: By analyzing the strongest resting-state functional connectivity between DMV and right precentral gyrus, left postcentral gyrus, and left brain leads in achalasia patients, individua...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

112 Patients enrolled

Trial Details

Trial ID

NCT06027190

Start Date

January 1 2024

End Date

December 31 2026

Last Update

September 21 2023

Active Locations (1)

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Nanjing Drum Tower Hospital

Nanjing, China, 210008