Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes (ABOH-PS)

  • STATUS
    Recruiting
  • End date
    Nov 21, 2023
  • participants needed
    30
  • sponsor
    Universitätsklinik für Neurologie, Innsbruck
Updated on 25 January 2022
movement disorder
orthostatic hypotension

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 hypotension (OH) in individuals suffering from Parkinson's disease (PD) or Parkinson variant multiple system atrophy (MSA-P).

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 individuals with MSA-P or PD with known or suspected OH.

At the Screening Visit, after patient information and written informed consent, the participants will first undergo a comprehensive neurological and cardiological evaluation, as well cardiovascular autonomic function testing to confirm the diagnosis of symptomatic, neurogenic OH.

Afterwards, the participants will be asked to wear physical activity monitoring (PAM) sensors for five consecutive days and to measure the blood pressure (BP) regularly following a home BP diary (i.e. Home Phase I).

On treatment day-1 (i.e. Visit 1), the participants will undergo an instrumented in-lab gait analysis, followed by a head-up tilt and active standing test. Afterwards, they will wear the first type of binder for two hours (either the investigational elastic abdominal binder or the placebo-comparator binder, depending on the randomization assignment). At the end of the two hours, the participants will repeat the in-lab gait analysis and the head-up tilt-/active standing test.

After one-day wash-out, the same procedure of treatment day-1 (i.e. Visit 1) will be repeated with the outstanding type of binder (i.e. treatment day-2, Visit 2).

At the end of this, all participants will be invited to wear the investigational elastic abdominal binder and the PAM sensors for five more days and to repeat the home BP measurements (i.e. Home Phase II).

A final follow-up visit is scheduled to return the PAM sensors, the BP monitor and to detect eventual adverse and serious adverse events occurred during Home Phase II.

Details
Condition Parkinson Disease, Multiple System Atrophy, Parkinson Variant, Orthostatic; Hypotension, Neurogenic
Treatment Elastic abdominal binder, Placebo binder
Clinical Study IdentifierNCT04920552
SponsorUniversitätsklinik für Neurologie, Innsbruck
Last Modified on25 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

diagnosis of possible or probable MSA-P (Gilman 2008) or clinically established PD (Postuma 2015)
to 80 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 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
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