Ignite Creation Date:
2024-05-06 @ 1:57 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01932905
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2013-08-27
Brief Title:
Deep rTMS in Central Neuropathic Pain Syndromes
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Deep rTMS in Central Neuropathic Pain Syndromes
Status:
COMPLETED
Status Verified Date:
2017-05
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:
DRTMS
Brief Summary:
Pain affects up to 30 of the general population In particular neuropathic pain NeP is caused by lesion or desease affecting peripheral or central somatosensory pathways and affects 7 of the adult population Despite the availability of evidence based pharmacological and surgical treatment for NeP about 50 of patients remais symptomatic despite best medical treatment Some neuropathic pain syndromes are specially refractory In particular central NeP is caused by disease or lesion to central structures involves in somatosensory integration of nociceptive information is non-responsive to drugs usually employed in other NeP syndromes Classical neuromodulatory techniques such as conventional repetitive Transcranial Magnetic Stimulation aiming at the motor of prefrontal cortices are ineffective to relieve pain in this population Recently new technology advances have made possible non-invasive stimulation of deeper cortical targets Some of them are activelly involved in the integration of the perception of pain such as the anterior cingulate cortex or the posterior insula The aim this study is to treat 90 patients with central pain post stroke pain spinal cord lesions after trauma or demyelinizating diseases under best medical pharmacological treatment in three different conditions AAC n 30 with the H-Coil Superior Posterior Insula SPI n30 cooled double cone coil double cool coil and shamn30 Each patients will undergo daily stimulation for a week then weekly stimulations for 3 months total of 17 sessions The main study outcome is pain relief at the last stimulation week visual-analogic scale Secondary end-points are changes in the McGill Pain Questionnaire Neuropathic Pain Symptom Inventory DN4 questionnaire SF -36 brief pain inventory and cognitive assessment including the trail making test A and B Strrop color interference test and subscalles from the CERAD All patients will undergo quantitative sensory test and measurements of cortical excitability over M1 before and after to treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None