Using abdominal binders to help manage low blood pressure in Parkinson's disease

Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes: a Randomized, Placebo-controlled, Double-blind, Crossover Phase II Trial

This study is testing if wearing an elastic abdominal binder can help people with Parkinson's disease manage low blood pressure symptoms better than a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Universitätsklinik für Neurologie, Innsbruck (Academic / other)
• Locations: 1 site (Innsbruck, Tyrol)
• Trial ID: NCT04920552 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of an elastic abdominal binder in managing symptomatic neurogenic orthostatic hypotension (OH) in patients with Parkinson's disease or multiple system atrophy. It is a monocentric, randomized, placebo-controlled, double-blind, crossover trial involving 30 participants. Patients will undergo comprehensive evaluations and wear physical activity monitoring sensors, followed by in-lab gait analysis and blood pressure tests while using either the investigational binder or a placebo. The study includes an open-label treatment extension phase for further assessment.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 to 85 with a diagnosis of Parkinson's disease or multiple system atrophy and symptomatic neurogenic orthostatic hypotension.

Not a fit: Patients with advanced stages of Parkinson's disease or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-pharmacological option for managing low blood pressure symptoms in patients with Parkinsonian syndromes.

How similar studies have performed: While the use of abdominal binders for this specific condition is novel, similar non-pharmacological interventions have shown promise in managing orthostatic hypotension in other populations.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Innsbruck, Tyrol

• Medical University Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)

Study contacts

• Study coordinator: Gregor K. Wenning, Prof. DDr. MSc

Conditions Parkinson Disease; Multiple System Atrophy, Parkinson Variant; Orthostatic; Hypotension, Neurogenic