Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-29 @ 1:29 AM
Study NCT ID:
NCT04833660
Status:
UNKNOWN
Last Update Posted:
2021-04-22
First Post:
2021-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
rTMS on Diabetic Peripheral Neuropathic Pain
Sponsor:
Min Cheol Chang
Organization:
Study Overview
Official Title:
The Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain: A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
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:
Background: Approximately half of the patients with long-standing diabetes are known to have diabetic peripheral neuropathy (DPN). Pain from DPN deteriorates the quality of life and hinders daily life activities.
Objectives: This study aimed to evaluate the effect of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) on the left primary motor cortex (M1) for neuropathic pain in the lower extremities due to DPN.
Methods: In this randomized trial, 22 patients with DPN will randomly assign to the rTMS group (10 Hz stimulation, five sessions) or the sham group. A numeric rating scale (NRS) will use to measure pain intensity before treatment and after 1 day and 1 week of the treatment. Physical and mental health status will evaluate using the Short Form 36-Item Health Survey (SF-36), comprising two subscales (physical and mental component scores \[PCSs and MCSs\]), at 1-week post-treatment.
Objectives: This study aimed to evaluate the effect of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) on the left primary motor cortex (M1) for neuropathic pain in the lower extremities due to DPN.
Methods: In this randomized trial, 22 patients with DPN will randomly assign to the rTMS group (10 Hz stimulation, five sessions) or the sham group. A numeric rating scale (NRS) will use to measure pain intensity before treatment and after 1 day and 1 week of the treatment. Physical and mental health status will evaluate using the Short Form 36-Item Health Survey (SF-36), comprising two subscales (physical and mental component scores \[PCSs and MCSs\]), at 1-week post-treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: