Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06027190
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-08-31
Brief Title:
Randomized Controlled Study of Optical 3D Navigated Repetitive Transcranial Magnetic Stimulation for Achalasia
Sponsor:
Zhang Nina
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 250 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
Statistical methods SPSS 250 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None