Combining VNS With PT Interventions for Individuals With PD

Not Applicable

Active, not recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT05871151
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - age between 35 and 80 years<br><br> - no walking aids<br><br> - stable medication 4 weeks prior to and during the study<br><br> - no falls in the past 6 months<br><br> - participant must have MD who is willing to provide oversight and approval for<br> clinically defined off state<br><br>Exclusion Criteria:<br><br> - mild cognitive impairment (MoCA <25)<br><br> - self reported depression<br><br> - antidepressive or antipsychotic medication<br><br> - participation in a VNS study in the past year<br><br> - disabling bradykinesia to ensure patients are able to participate in intensive<br> physiotherapy (based on clinical impression and in accordance to UPDRS part III item<br> 14 - to be administered in clinic)<br><br> - prior history of cardiovascular, neurological or musculoskeletal disorders known to<br> interfere with testing PD features<br><br> - implanted medical device of any type<br><br> - history of seizures<br><br> - peripheral neuropathy including temporal mandibular disorders and Bells Palsy, and<br><br> - vasovagal syncope.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MDS-UPDRS Part III;6MWT;10MWT;Mini-Best Test;FGA;mCTSIB

Secondary Outcome Measures

Name	Time	Method
MoCA;DKEFS Color Word Interference Test;HVLT;DST;DSST;N-back;Promise Neuro-QOL;SF-36;DKEFS Trails Making Test (Trails);DKEFS Verbal Learning Test (VLT)