Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes

NCT ID: NCT04920552

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2025-06-30

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).

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Elastic abdominal binder first

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).

Group Type: ACTIVE_COMPARATOR

Elastic abdominal binder

Intervention Type: 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).

Placebo binder

Intervention Type: 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.

Placebo binder first

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).

Group Type: PLACEBO_COMPARATOR

Elastic abdominal binder

Intervention Type: 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).

Placebo binder

Intervention Type: 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.

Interventions

Elastic abdominal binder

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).

Intervention Type: DEVICE

Placebo binder

"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.

Intervention Type: DEVICE

Other Intervention Names

"ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH; "Clima Care" body warmer, Bort Medical GmbH

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinik für Neurologie, Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Gregor Wenning

Head of Division of Neurobiology, Department of Neurology, Medical University of Innsbruck; Principle Investigator; Professor DDr. MD MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Gregor K. Wenning, Prof. DDr. MSc

Role: CONTACT

gregor.wenning@i-med.ac.at

004351250481811

Alessandra Fanciulli, DDr.

Role: CONTACT

alessandra.fanciulli@i-med.ac.at

004351250483238

Facility Contacts

Gregor K. Wenning, Prof. DDr. MSc.

Role: primary

gregor.wenning@i-med.ac.at

004351250481811

Alessandra Fanciulli, DDr.

Role: backup

alessandra.fanciulli@i-med.ac.at

004351250483238

References

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.

Reference Type: BACKGROUND

PMID: 30363559 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25587949 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32716319 (View on PubMed)

Other Identifiers

1483/2020

Identifier Type: -

Identifier Source: org_study_id