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

NCT06027190 | Not Yet Recruiting DMC

• 1 other identifier: 2023-160-02
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Achalasia; Transcranial Magnetic Stimulation, Repetitive; Vagus Nerve Motor Disorder; Functional Magnetic Resonance Imaging

Keywords

Achalasia; rTMS; fMRI; Non-invasive

Outcome Measures

Primary Outcomes (3)

• Eckardt score

  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.

• Real-time esophageal barium meal examination

  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.

• High-resolution esophageal manometry（HREM）

  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 Outcomes (2)

• Heart rate variability assessment

  Measured immediately after intervention.

• Neurotransmitter detection analysis

  Measured immediately after intervention.

Study Arms (2)

Sham group

SHAM COMPARATOR

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

rTMS group

EXPERIMENTAL

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

Interventions

Repetitive transcranial magnetic stimulation DEVICE

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.

rTMS group

Sham DEVICE

Placebo coil (Magstim Company, Whitland, UK):

Sham group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhang Nina: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Esophageal Achalasia; Vagus Nerve Diseases

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Nina Zhang

CONTACT

18652782446; zhangnina@njglyy.com

Xinyi Lu

CONTACT

17365386771; luxinyi0809@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: In patients with achalasia diagnosed by clinical symptoms, HREM and barium meal examination, functional connectivity analysis of DMV with three brain regions (precentral gyrus, postcentral gyrus and insula) was performed by scanning T1 structural magnetic resonance imaging, and brain regions with the strongest positive functional connectivity with DMV were selected as individualized rTMS targets by optical 3D navigation. 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.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)