Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792072
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-03-30
First Post:
2022-12-07
Brief Title:
rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
High Frequency rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-09
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:
Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients
This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing underlying brain metabolism and brain plasticity using rs-fMRI MRS and Paired-pulse stimulation respectively in those patients
Subjects will be randomized into two groups to receive real or sham rTMS protocol A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects Sham stimulation will be delivered using a sham coil providing the same auditory and sensory stimuli
One daily rTMS session for 5 days of HF-rTMS will be delivered through an H-coil applied to the primary motor area of the leg Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100 of resting motor threshold RMT with an intertrain interval of 30s
This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing underlying brain metabolism and brain plasticity using rs-fMRI MRS and Paired-pulse stimulation respectively in those patients
Subjects will be randomized into two groups to receive real or sham rTMS protocol A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects Sham stimulation will be delivered using a sham coil providing the same auditory and sensory stimuli
One daily rTMS session for 5 days of HF-rTMS will be delivered through an H-coil applied to the primary motor area of the leg Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100 of resting motor threshold RMT with an intertrain interval of 30s
Detailed Description:
None
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