Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920318
Status:
RECRUITING
Last Update Posted:
2023-10-02
First Post:
2021-06-01
Brief Title:
Enhancing Language Function in Primary Progressive Aphasia
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Enhancing Language Function in Primary Progressive Aphasia PPA With Transcranial Direct Current Stimulation tDCS
Status:
RECRUITING
Status Verified Date:
2023-09
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:
PPA
Brief Summary:
This studys goal is to use non-invasive brain stimulation NBS techniques to treat language impairment associated with Primary Progressive Aphasia PPA The purpose of this study is to combine behavioral language intervention with individualized noninvasive brain stimulation techniques called transcranial direct current stimulation tDCS to help the brain reorganize around damage and improve language functions
Detailed Description:
Primary Progressive Aphasia PPA is a neurodegenerative disorder that selectively affects language comprehension andor production with initial preservation of other cognitive domains As tDCS has not been extensively studied in PPA the investigators will measure both short- and long-term effects of stimulation in patients with this neurodegenerative disorder that affects specific language regions Previous research suggests that neurostimulation with tDCS can safely induce changes in neural plasticity that can lead to long-term restoration of synaptic function Thus individually targeted stimulation to structurally preserved but dysfunctional regions may be able to produce behavioral improvements in primary progressive aphasia PPA
TDCS is a method of stimulating the brain that does not require any sedation or surgery TDCS is a technique that sends a weak electrical current through the scalp to stimulate the brain areas below The information gained from this research study will aid in the development of therapies to improve language in people with neurological conditions that affect language use
TDCS will be applied over the activated area identified with the functional magnetic resonance imaging fMRI fMRI-localizer task This approach will allow for individually optimized tDCS electrode placement It will also account for potential inter-participant variability in the brain atrophy and language organization
Summary of study sequence and procedures
Week 1 Baseline screening language testing one event-related brain potential EEG-ERP session Weeks 2 fMRI session to determine most effective treatment Weeks 3-4 tDCS with Language Treatment Part 1 Weeks 5 and 6 rest-period post-treatment assessment Weeks 7 to 8 TDCS with Language Treatment Part 2 Weeks 9 and 10 rest period post-treatment assessment 2-month follow-up language assessment one MRI scan one EEG-ERP session
TDCS is a method of stimulating the brain that does not require any sedation or surgery TDCS is a technique that sends a weak electrical current through the scalp to stimulate the brain areas below The information gained from this research study will aid in the development of therapies to improve language in people with neurological conditions that affect language use
TDCS will be applied over the activated area identified with the functional magnetic resonance imaging fMRI fMRI-localizer task This approach will allow for individually optimized tDCS electrode placement It will also account for potential inter-participant variability in the brain atrophy and language organization
Summary of study sequence and procedures
Week 1 Baseline screening language testing one event-related brain potential EEG-ERP session Weeks 2 fMRI session to determine most effective treatment Weeks 3-4 tDCS with Language Treatment Part 1 Weeks 5 and 6 rest-period post-treatment assessment Weeks 7 to 8 TDCS with Language Treatment Part 2 Weeks 9 and 10 rest period post-treatment assessment 2-month follow-up language assessment one MRI scan one EEG-ERP session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None