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

September 15, 2023 updated by: Zhang Nina

To Investigate the Clinical Efficacy of Optical 3D Navigation Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Achalasia, Optimize the Treatment Parameters, and Provide a Noninvasive Treatment Strategy for Achalasia

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 comprehensive evaluation of clinical symptoms, HREM, and barium meal examination, optimize rTMS treatment parameters, and provide an effective and noninvasive new treatment strategy for achalasia. The main questions it aims to answer are:

  1. To investigate the clinical efficacy of individualized treatment of achalasia with optical 3D navigation repetitive transcranial magnetic stimulation.
  2. Optimize rTMS parameters to achieve the best clinical treatment.

Participants will need to fill out the Eckardt score scale and SF-36 quality of life scale, undergo cranial T1 structural magnetic resonance for functional connectivity analysis, and select the brain region with the strongest positive functional connectivity to the DMV as the rTMS target. All patients were randomly divided into four groups: sham-rTMS group, 5Hz-rTMS group, 10Hz-rTMS group, and 30Hz-rTMS group, and each group received acute and chronic stimulation, respectively. In the acute stimulation stage, patients only need to do rTMS once, and HREM and HRV detection are given before and after rTMS (stimulation for 1s, interval for 4s, 10 pulses per second, receiving a total of 3000 pulses); in the chronic stimulation stage, patients receive 25 minutes of rTMS actual stimulation or sham stimulation each time, lasting for 20 times, which is completed within 30 days, and the actual stimulation parameters are the same as those of acute stimulation, and the sham stimulation coil is consistent with the appearance and sound of proper stimulation, but there is no substantial stimulation. High-definition esophageal manometry, timed barium meal, heart rate coefficient of variation, and serum neurotransmitters were performed before and after chronic stimulation. Finally, a weekly telephone follow-up was performed for 12 weeks, including Eckardt score and SF-36 quality of life scale.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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, individualized rTMS treatment with optical 3D navigation was applied to relax LES and relieve the clinical symptoms of dysphagia.

Statistical methods: SPSS 25.0 software was used to process the data, symptom score, manometry parameters, serum transmitters and other quantitative indicators. If they met the normal distribution, they were expressed as Mean ± SD. The t-test was performed for the comparison between the two groups; if they did not obey the normal distribution, the median (quartile) was used for statistical description. The rank sum test was used for the comparison between the two groups. Enumeration data were described using number of cases (percentage), and X2 test, corrected X2 test, or Fisher exact test were performed for comparison between the 2 groups.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Nanjing, China, 210008
        • Nanjing Drum Tower Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham group
Intervention Name and Specification: Placebo coil (Magstim Company, Whitland, UK): looks and sounds consistent with true coil but does not produce current stimulation.
Device: Sham
Placebo coil (Magstim Company, Whitland, UK):
Experimental: rTMS group
  1. 5Hz-rTMS group
  2. 10Hz-rTMS group
  3. 30Hz-rTMS group

Intervention Name and Specification:

  1. Transcranial magnetic stimulator (M-100 Ultimate, Yingzhi Technology Co., Ltd., China)
  2. 70 mm diameter figure-of-eight coil (BY90A, Yingzhi Technology Co., Ltd., China).

Each group received acute and chronic stimulation, respectively. In the acute stimulation stage, patients only needed to do rTMS once, and HREM and HRV were administered before and after rTMS; in the chronic stimulation stage, patients received 25 minutes of rTMS true stimulation each time a day for 20 times, which was completed within 30 days, and the true stimulation parameters were the same as those of acute stimulation.
Device: Repetitive transcranial magnetic stimulation

Intervention Name and Specification

  1. Transcranial magnetic stimulator (M-100 Ultimate, Yingzhi Technology Co., Ltd., China) .
  2. 70-mm-diameter figure-of-eight coil (BY90A, Yingzhi Technology Co., Ltd., China). 3) Placebo coil (Magstim Company, Whitland, UK): the appearance and sound were consistent with the true coil, but no current stimulation was produced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-time esophageal barium meal examination
Time Frame: Measured immediately after intervention.
The severity of the patient 's condition and the therapeutic effect were evaluated by defining the height and maximum width of the residual barium area.
Measured immediately after intervention.
Eckardt score
Time Frame: Measured immediately after intervention.
The Eckardt scoring system is used to assess the severity of symptoms, with 0 to 1 in grade 0, 2 to 3 in grade I., 4 to 6 in grade II., and > 6 in grade III. The more severe the symptoms, the higher the score, and can also be used for efficacy assessment.
Measured immediately after intervention.
High-resolution esophageal manometry（HREM）
Time Frame: Measured immediately after intervention.
HREM is the gold standard for the diagnosis of achalasia of cardia (AC), which can assess the relaxation ability of the lower esophageal sphincter (LES) and the contraction ability of the esophageal body. HREM dynamically collects the mean pressure data of multiple parts of the whole esophagus in real time, and converts the linear manometry pattern into color pressure topography. The basic manometry parameters include integrated relaxation pressure (IRP) and lower esophageal sphincter pressure (LESP), which can more truly reflect the relaxation function of the gastroesophageal junction (EGJ) and are the key indicators for the diagnosis of AC.
Measured immediately after intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability assessment
Time Frame: Measured immediately after intervention.
Dynamic electrocardiogram recording analysis of sympathetic vagal activity.
Measured immediately after intervention.
Neurotransmitter detection analysis
Time Frame: Measured immediately after intervention.
Serum ACh, NO and VIP
Measured immediately after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhang Nina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-160-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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