Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes

NCT04920552 | Unknown DMC

• 1 other identifier: 1483/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.

  3 days

Secondary Outcomes (38)

• Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.

  3 days

• Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.

  3 days

• Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.

  3 days

• Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.

  3 days

• Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.

  3 days

Study Arms (2)

Placebo binder first

PLACEBO COMPARATOR

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).

Device: Elastic abdominal binder; Device: Placebo binder

Elastic abdominal binder first

ACTIVE COMPARATOR

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).

Device: Elastic abdominal binder; Device: Placebo binder

Interventions

Elastic abdominal binder DEVICE

The "ABDO-SYNCRO 3-BAHNIG" is an elastic abdominal binder with a 3-stripes Velcro fastening, capable of developing a 20 ± 2 mmHg pressure on the abdominal wall. This device will be tested as potentially beneficial with respect to the mentioned primary and secondary outcomes. The investigators anticipate to use this elastic abdominal binder, since participants of a previous trial reported this device to be comfortable enough and to have used it regularly during the open-label follow-up phase. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer (SYNCRO-MED GmbH).

Also known as: "ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH

Elastic abdominal binder first; Placebo binder first

Placebo binder DEVICE

"Clima Care" is a simple body warmer, developing maximal 3±2 mmHg pressure on the abdominal wall. This device will be used as placebo comparator of the present clinical trial. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer.

Also known as: "Clima Care" body warmer, Bort Medical GmbH

Elastic abdominal binder first; Placebo binder first

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of possible or probable MSA-P (Gilman 2008) or clinically established PD (Postuma 2015);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinik für Neurologie, Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (3)

• Fanciulli A, Goebel G, Metzler B, Sprenger F, Poewe W, Wenning GK, Seppi K. Elastic Abdominal Binders Attenuate Orthostatic Hypotension in Parkinson's Disease. Mov Disord Clin Pract. 2015 Nov 27;3(2):156-160. doi: 10.1002/mdc3.12270. eCollection 2016 Mar-Apr.

  PMID: 30363559 BACKGROUND

• Fanciulli A, Wenning GK. Multiple-system atrophy. N Engl J Med. 2015 Jan 15;372(3):249-63. doi: 10.1056/NEJMra1311488. No abstract available.

  PMID: 25587949 BACKGROUND

• Fanciulli A, Leys F, Falup-Pecurariu C, Thijs R, Wenning GK. Management of Orthostatic Hypotension in Parkinson's Disease. J Parkinsons Dis. 2020;10(s1):S57-S64. doi: 10.3233/JPD-202036.

  PMID: 32716319 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Hypotension

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gregor K. Wenning, Prof. DDr. MSc

CONTACT

004351250481811; gregor.wenning@i-med.ac.at

Alessandra Fanciulli, DDr.

CONTACT

004351250483238; alessandra.fanciulli@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Division of Neurobiology, Department of Neurology, Medical University of Innsbruck; Principle Investigator; Professor DDr. MD MSc

Model Details: monocentric, randomized, placebo-controlled, double-blind, crossover phase II trial with an open-label treatment extension phase

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 10, 2021
• Study Start: May 17, 2021
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

AU (1)