Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)

NCT01971008 | Completed Phase 2 Results DMC

• 1 other identifier: ABOHP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to determine whether the use of an abdominal binder is effective in the non-pharmacological management of orthostatic hypotension in patients suffering from Parkinson's disease

Conditions

Parkinson's Disease; Neurogenic Orthostatic Hypotension in Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Change in Mean Blood Pressure (mmHg) After 3 Minutes of Passive Orthostatic Challenge From Baseline, When Wearing an Elastic Abdominal Binder vs a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension

  Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1. Mean blood pressure was calculated as: (diastolic blood pressure +1/3(systolic blood pressure - diastolic blood pressure).

  3 days

Secondary Outcomes (5)

• Change in Systolic Blood Pressure (mmHg) After 3 Minutes of Passive Orthostatic Challenge From Baseline When Wearing an Elastic Abdominal Binder vs a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension

  3 days

• Change in Diastolic Blood Pressure (mmHg) After 3 Minutes of Passive Orthostatic Challenge From Baseline if Wearing an Elastic Abdominal Binder vs a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension

  3 days

• Change in Mean Blood Pressure (mmHg) After 3 Minutes of Active Orthostatic Challenge From Baseline When Wearing an Elastic Abdominal Binder Versus a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension

  3 days

• Change in Supine Mean Blood Pressure (mmHg) if Wearing an Elastic Abdominal Binder vs a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension

  3 days

• Change in Orthostatic Hypotension Questionnaire Total Score After 4-weeks Open Label Trial With an Elastic Abdominal Binder With Respect to Baseline in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension

  4 weeks

Study Arms (2)

Elastic abdominal binder, then placebo binder

EXPERIMENTAL

Patients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours on day 1 and a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours on day 3, after wash-out on day 2

Device: Elastic abdominal binder

Placebo binder, then elastic abdominal binder

EXPERIMENTAL

Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours on day 1 and an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours on day 3, after wash-out on day 2

Device: Placebo binder

Interventions

Elastic abdominal binder DEVICE

Also known as: "Abdosyncro" Abdominalbandage, Syncro Med GmbH

Elastic abdominal binder, then placebo binder

Placebo binder DEVICE

Also known as: "Clima Care" Body warmer, Bort Medical

Placebo binder, then elastic abdominal binder

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic PD
• Hoehn \& Yahr stadium \< or = 4
• Age: 40-90
• Laboratory confirmed neurogenic orthostatic hypotension (NOH)
• Stable pharmacological therapy in the last 6 weeks
• Full legal competence

You may not qualify if:

• Other major neurologic or psychiatric diseases
• Untreated diabetes mellitus with clinical features of peripheral neuropathy
• Major cardiac diseases (ischemic, structural, arrhythmias)
• Evidence of varices (venous insufficiency stage \> or = C2, "varicose veins")
• Known or suspected pregnancy
• Breast feeding

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Department of Neurology - Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (3)

• Seppi K, Weintraub D, Coelho M, Perez-Lloret S, Fox SH, Katzenschlager R, Hametner EM, Poewe W, Rascol O, Goetz CG, Sampaio C. The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease. Mov Disord. 2011 Oct;26 Suppl 3(0 3):S42-80. doi: 10.1002/mds.23884.

  PMID: 22021174 BACKGROUND

• Ferreira JJ, Katzenschlager R, Bloem BR, Bonuccelli U, Burn D, Deuschl G, Dietrichs E, Fabbrini G, Friedman A, Kanovsky P, Kostic V, Nieuwboer A, Odin P, Poewe W, Rascol O, Sampaio C, Schupbach M, Tolosa E, Trenkwalder C, Schapira A, Berardelli A, Oertel WH. Summary of the recommendations of the EFNS/MDS-ES review on therapeutic management of Parkinson's disease. Eur J Neurol. 2013 Jan;20(1):5-15. doi: 10.1111/j.1468-1331.2012.03866.x.

  PMID: 23279439 BACKGROUND

• Zesiewicz TA, Sullivan KL, Arnulf I, Chaudhuri KR, Morgan JC, Gronseth GS, Miyasaki J, Iverson DJ, Weiner WJ; Quality Standards Subcommittee of the American Academy of Neurology. Practice Parameter: treatment of nonmotor symptoms of Parkinson disease [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2010 Mar 16;74(11):924-31. doi: 10.1212/WNL.0b013e3181d55f24.

  PMID: 20231670 BACKGROUND

Related Links

• Coordination center for clinical studies of the Medical University Innsbruck

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Prof. Dr. Klaus Seppi
• Organization: Innsbruck Medical University

klaus.seppi@tirol-kliniken.at

004351250481498

Study Officials

• Klaus Seppi, Univ. Prof. Dr.

  Department of Neurology - Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr.

Model Details: N/A (the Intervention type in the present study was an elastic abdominal binder, which is a medical device)

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 28, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 10, 2023
• Results First Posted: March 10, 2023

Record last verified: 2022-06

Locations

AU (1)