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

Universitätsklinik für Neurologie, Innsbruck

Status: Enrolling

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

Treatments: Device: Elastic abdominal binder; Device: Placebo binder

Study type: Interventional

Funder types: Other

Identifiers

NCT04920552

1483/2020

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Placebo binder first

Placebo Comparator group

Description:

Participants in this arm will wear the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).

Treatment:

Device: Placebo binder

Device: Elastic abdominal binder

Elastic abdominal binder first

Active Comparator group

Description:

Participants in this arm will wear the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).

Treatment:

Device: Placebo binder

Device: Elastic abdominal binder