Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT04816305
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2020-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
Sponsor:
Universidade Federal de Pernambuco
Organization:
Study Overview
Official Title:
Project NEUROMOD: Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
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:
This study aims to investigate if the size effect of repetitive magnetic transcranial stimulation in the paretic upper limb in patients after stroke is influenced by the therapeutic decision.
Detailed Description:
After the patients and volunteers signed an informed consent form they will be classified and randomized using a website (randomization.com) by a non-involved researcher.
All patients and volunteers will be assigned to groups (arms) after being tried:
(i) rTMS-DIR: in which the patients will be submitted to a customized treatment with repetitive transcranial magnetic stimulation (rTMS) based in neurophysiological assessments; (ii) rTMS: patients will be submitted to standard treatment in the lesioned or non-lesioned hemisphere based in neurophysiological assessments; (iii) rTMS sham: each patient will receive a sham intervention that emits the same sound as the real stimulation;
In each group, the patients will be submitted to 10 sessions for two weeks, five days a week in which will receive the rTMS followed by 45 minutes of neurofunctional physiotherapy. All outcomes will be assessed before and after the 10 sessions.
All patients and volunteers will be assigned to groups (arms) after being tried:
(i) rTMS-DIR: in which the patients will be submitted to a customized treatment with repetitive transcranial magnetic stimulation (rTMS) based in neurophysiological assessments; (ii) rTMS: patients will be submitted to standard treatment in the lesioned or non-lesioned hemisphere based in neurophysiological assessments; (iii) rTMS sham: each patient will receive a sham intervention that emits the same sound as the real stimulation;
In each group, the patients will be submitted to 10 sessions for two weeks, five days a week in which will receive the rTMS followed by 45 minutes of neurofunctional physiotherapy. All outcomes will be assessed before and after the 10 sessions.
Study Oversight
Has Oversight DMC:
True
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?: