Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416553
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-08
Brief Title:
Effect of Speech Therapy in Combination With Non-invasive Brain Stimulation on Speech of Patients With Parkinsons Disease
Sponsor:
Masaryk University
Organization:
Masaryk University
Study Overview
Official Title:
Home-based Non-invasive Brain Stimulation in Combination With Lee Silverman Voice Treatment on Hypokinetic Dysarthria in Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Up to 90 of patients with Parkinsons disease PD have hypokinetic dysarthria HD in the early phase of the illness HD is characterized by a harsh breathy voice quality reduced variability of pitch and loudness and imprecise articulation This project investigates the novel combination of speech therapy and home-based non-invasive brain stimulation tDCS treatment in order to increase overall positive effects on HD in PD Using a novel multimodal analysis approach based on functional magnetic resonance and acoustic signal processing we will be able to monitor changes in different domains of speech as well as associated changes in brain plasticity
Detailed Description:
Study will investigate the long-term effects of repeated 20 sessions of home-based tDCS as an add-on to well-established remote LSVT ie the gold standard procedure for HD treatment as compared to LSVT alone coupled with sham stimulation in patients with PD in their on dopaminergic condition without dyskinesias
A two parallel-group double-blinded randomized sham-stimulation-controlled design will be used Forty PD patients will be randomized into two parallel groups by independent researcher by a computer-generated random number list 20 subjects in each arm Participants in the real tDCS group and the sham tDCS group will undergo a baseline assessment V0 a follow-up assessment after four weeks of combined tDCS and LSVT treatments V1 and another follow-up assessment 8 weeks after the baseline assessment V2 Each visit will consist of EEG speech tasks recording and speech evaluation by a speech therapist MR scanning will be done at V0 and V1 Both groups will undergo the same speech therapy LSVT via telepractice as the gold standard treatment for HD in combination with real or sham tDCS
A two parallel-group double-blinded randomized sham-stimulation-controlled design will be used Forty PD patients will be randomized into two parallel groups by independent researcher by a computer-generated random number list 20 subjects in each arm Participants in the real tDCS group and the sham tDCS group will undergo a baseline assessment V0 a follow-up assessment after four weeks of combined tDCS and LSVT treatments V1 and another follow-up assessment 8 weeks after the baseline assessment V2 Each visit will consist of EEG speech tasks recording and speech evaluation by a speech therapist MR scanning will be done at V0 and V1 Both groups will undergo the same speech therapy LSVT via telepractice as the gold standard treatment for HD in combination with real or sham tDCS
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