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Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease (TALISMAN-2)

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

Hypoxia through modified hypoxic generator

Normoxia through hypoxic generator without active elements

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Informed consent Clinical diagnosis of Parkinson's disease by a movement disorder specialized neurologist. Hoehn and Yahr staging 1 to and including 3 (indicating mild to moderate PD). Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: Individuals with diseases leading to restrictive and obstructive pulmonary diseases, sleep apnea and cardiac output deficits, such as pulmonary fibrosis, COPD, sleep apnea or excessive alcoholic intake, and congestive heart failure respectively Individuals with coronary artery disease NYHA classes III and IV Arterial blood gas abnormalities at screening procedure Individuals with shortness of breath or other airway or breathing-related inconvenience related to lack of dopaminergic medication Inability for in-clinic measurements in OFF phase Individuals with active deep brain stimulation

Sites / Locations

Dpt. of Physiology, Radboud University Medical CenterRecruiting
Radboud University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Active intervention

Arm Description

Hypoxic generator without active elements, pulsewise ventilation assured to ascertain blinding

FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia (intermittent hypoxia)

Outcomes

Primary Outcome Measures

Number and nature of adverse events

Feasibility questionnaire, overall study success

Higher indicates better score

Secondary Outcome Measures

MDS-UPDRS part II and III

Lower indicates better score

Purdue pegboard test (PPT)

Higher indicates better score

Timed up & Go Test (TUGT)

Lower indicates better score

Exercise tolerance (6-minute walk test, 6MWT)

Higher indicates better score

Accelerometry data for tremor amplitude

Lower indicates better score

Accelerometry data for pronation-supination

Higher indicates better score

Hematocrit

Higher indicates better result

Neurofilament light chain (NfL)

Higher indicates better result

BDNF

Higher indicates better result

Platelet-derived growth factor receptor beta (PDGFRβ)

Higher indicates better result

Clusterin

Higher indicates better result

GFAP

Higher indicates better result

UCH-L1

Higher indicates better result

Full Information

NCT ID

NCT05948761

First Posted

June 20, 2023

Last Updated

July 13, 2023

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05948761

Brief Title

Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease

Acronym

TALISMAN-2

Official Title

A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 4, 2023 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To explore the safety, feasibility and net symptomatic effects of multiple (3x/week, for 4 weeks) intermittent hypoxia treatment sessions in individuals with PD. Secondary outcomes include exploring induction of relevant neuroprotective pathways as measured in serum.

Detailed Description

Intermittent hypoxia therapy is a non-pharmacological intervention used by athletes and individuals with cardiovascular disease, amongst others. The safety and feasibility of (intermittent) hypoxia therapy and its short-term effects on Parkinson's disease (PD) symptoms were assessed in a previous exploratory phase I trial. However, the net effects of multiple hypoxia treatment sessions on PD symptoms are unknown. The results of the previous phase I trial informed the study design of the newly proposed phase 1b-2a safety and efficacy trial. 45 minutes of normobaric intermittent hypoxia (FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia) will be delivered via a hypoxicator (a device that titrates decreased fractional oxygen from room air) through an oxygen mask in the hospital and subsequently at participants' homes. Interventions will be conducted 3 times a week, for 4 weeks in total.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Hypoxic generator without active elements, pulsewise ventilation assured to ascertain blinding

Arm Title

Active intervention

Arm Type

Experimental

Arm Description

FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia (intermittent hypoxia)

Intervention Type

Other

Intervention Name(s)

Hypoxia through modified hypoxic generator

Intervention Description

Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants.

Intervention Type

Other

Intervention Name(s)

Normoxia through hypoxic generator without active elements

Intervention Description

Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants, without active elements.

Primary Outcome Measure Information:

Title

Number and nature of adverse events

Time Frame

2 months

Title

Feasibility questionnaire, overall study success

Description

Higher indicates better score

Time Frame

1 month

Secondary Outcome Measure Information:

Title

MDS-UPDRS part II and III

Description

Lower indicates better score

Time Frame

1 month

Title

Purdue pegboard test (PPT)

Description

Higher indicates better score

Time Frame

1 month

Title

Timed up & Go Test (TUGT)

Description

Lower indicates better score

Time Frame

1 month

Title

Exercise tolerance (6-minute walk test, 6MWT)

Description

Higher indicates better score

Time Frame

1 month

Title

Accelerometry data for tremor amplitude

Description

Lower indicates better score

Time Frame

1 month

Title

Accelerometry data for pronation-supination

Description

Higher indicates better score

Time Frame

1 month

Title

Hematocrit

Description

Higher indicates better result

Time Frame

1 month

Title

Neurofilament light chain (NfL)

Description

Higher indicates better result

Time Frame

1 month

Title

BDNF

Description

Higher indicates better result

Time Frame

1 month

Title

Platelet-derived growth factor receptor beta (PDGFRβ)

Description

Higher indicates better result

Time Frame

1 month

Title

Clusterin

Description

Higher indicates better result

Time Frame

1 month

Title

GFAP

Description

Higher indicates better result

Time Frame

1 month

Title

UCH-L1

Description

Higher indicates better result

Time Frame

1 month

Other Pre-specified Outcome Measures:

Title

Parkinson's disease Questionnaire-39 (PDQ-39)

Description

Lower indicates better score

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jules M. Janssen Daalen, MD

Phone

0031243616600

jules.m.janssendaalen@radboudumc.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Marjan J. Meinders, PhD

Facility Information:

Facility Name

Dpt. of Physiology, Radboud University Medical Center

City

Nijmegen

ZIP/Postal Code

6525EX

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jules M Janssen Daalen, MD

jules.m.janssendaalen@radboudumc.nl

First Name & Middle Initial & Last Name & Degree

Bastiaan R Bloem, MD, PhD

Facility Name

Radboud University Medical Center

City

Nijmegen

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jules M. Janssen Daalen, MD

jules.m.janssendaalen@radboudumc.nl

First Name & Middle Initial & Last Name & Degree

Bastiaan R. Bloem, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized data will be shared with The Michael J. Fox Foundation for Parkinson's Research (the study funder). This data may be kept for storage at a central repository either hosted by The Michael J. Fox Foundation, its collaborators, or consultants and will be kept indefinitely. Anonymized data will be made publicly available for the intended use of research in Parkinson's disease as well as other biomedical research studies that may not be related to Parkinson's disease.

IPD Sharing Time Frame

1.5 years

Citations:

PubMed Identifier

35836147

Citation

Janssen Daalen JM, Meinders MJ, Giardina F, Roes KCB, Stunnenberg BC, Mathur S, Ainslie PN, Thijssen DHJ, Bloem BR. Multiple N-of-1 trials to investigate hypoxia therapy in Parkinson's disease: study rationale and protocol. BMC Neurol. 2022 Jul 14;22(1):262. doi: 10.1186/s12883-022-02770-7.

Results Reference

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Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease

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