Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842473
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-04-24
Brief Title:
Long-term Effect of TMS in Primary Progressive Aphasia
Sponsor:
Hospital San Carlos Madrid
Organization:
Hospital San Carlos Madrid
Study Overview
Official Title:
Long-term Effect of Transcranial Magnetic Stimulation in Primary Progressive Aphasia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
RECONNECT
Brief Summary:
There are very few treatments for neurodegenerative disorders and the efficacy of these treatments is generally modest Recent studies have shown a short-term positive effect of non-invasive neuromodulation techniques such as transcranial magnetic stimulation TMS in primary progressive aphasia PPA PPA is a clinical syndrome associated with Alzheimers disease and Frontotemporal degeneration The aim of this study is to compare the effect of TMS and language therapy versus language therapy and sham TMS in patients with PPA during 6 months A prospective randomized controlled double-blind and parallel clinical trial will be conducted The changes in brain metabolism using FDG-PET language neuropsychiatric symptoms and daily-living activities will be assessed Connectivity changes using electroencephalography will also be examined In addition a subgroup of patients will be assessed with multimodal MRI structural and functional and blood biomarkers As a result of this project valuable information about the long-term efficacy of non-invasive brain stimulation in PPA will be obtained as well as the mechanisms of the therapy and clinical and neuroimaging factors associated with therapy response
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