Status:
UNKNOWN
Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes
Lead Sponsor:
Universitätsklinik für Neurologie, Innsbruck
Conditions:
Parkinson Disease
Multiple System Atrophy, Parkinson Variant
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The purpose of the present clinical trial is to determine whether the use of an elastic abdominal binder is effective in the non-pharmacological management of symptomatic, neurogenic orthostatic hypot...
Detailed Description
This is a monocentric, randomized, placebo-controlled, double-blind, crossover phase II clinical trial with an open-label treatment extension phase. The investigators plan to recruit n = 30 individual...
Eligibility Criteria
Inclusion
- diagnosis of possible or probable MSA-P (Gilman 2008) or clinically established PD (Postuma 2015);
- 50 to 85 years of age;
- laboratory-confirmed symptomatic (i.e. OHQ - OH Symptom Assessment item #1 ≥ 4), neurogenic OH at screening visit or previously diagnosed as such (i.e. neurogenic OH ratio \[≤ 0.492 Δ heart rate rise/systolic BP fall\] or missing BP overshoot at phase IV of Valsalva maneuver;
- stable medication schedule in the preceding 3 weeks;
- no infectious disease in the preceding 3 weeks;
- Hoehn \& Yahr stage ≤ 3;
- gait item of the Unified MSA Rating Scale (UMSARS) Part II or the Movement Disorder Society - Unified PD Rating Scale (MDS-UPDRS) Part III score \< 3;
- body sway item of the UMSARS II/MDS-UPDRS III score \< 3;
- arising from chair item of the UMSARS II/MDS-UPDRS III score \< 3;
- full legal capacity;
- written informed consent has been obtained.
Exclusion
- participation in other interventional trials;
- prescribed and regular use of abdominal binders OR compression stockings for OH treatment;
- other major neurologic or psychiatric diseases which could influence OH or gait;
- untreated diabetes mellitus with clinical features of peripheral neuropathy;
- non-neurological causes of gait disorders;
- major cardiac diseases (ischemic, structural, arrhythmias);
- evidence of varices (venous insufficiency stage ≥ C2, "varicose veins");
- known abdominal aortic aneurism;
- indwelling catheterisation;
- recent surgery (3 months) requiring anaesthesia;
- known or suspected pregnancy;
- breast-feeding female participants.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04920552
Start Date
May 17 2021
End Date
June 1 2025
Last Update
August 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020