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

Parkinson Disease Clinical Trial

— TALISMAN-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05948761
• Other study ID #: 114210
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 4, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2023
• Source: Radboud University Medical Center
• Contact: Jules M. Janssen Daalen, MD
• Phone: 0031243616600
• Email: jules.m.janssendaalen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Parkinson Disease

Intervention

Other:
• Hypoxia through modified hypoxic generator
Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants.
• Normoxia through hypoxic generator without active elements
Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants, without active elements.

Locations

Country	Name	City	State
Netherlands	Dpt. of Physiology, Radboud University Medical Center	Nijmegen
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parkinson's disease Questionnaire-39 (PDQ-39)	Lower indicates better score	1 month
Primary	Number and nature of adverse events		2 months
Primary	Feasibility questionnaire, overall study success	Higher indicates better score	1 month
Secondary	MDS-UPDRS part II and III	Lower indicates better score	1 month
Secondary	Purdue pegboard test (PPT)	Higher indicates better score	1 month
Secondary	Timed up & Go Test (TUGT)	Lower indicates better score	1 month
Secondary	Exercise tolerance (6-minute walk test, 6MWT)	Higher indicates better score	1 month
Secondary	Accelerometry data for tremor amplitude	Lower indicates better score	1 month
Secondary	Accelerometry data for pronation-supination	Higher indicates better score	1 month
Secondary	Hematocrit	Higher indicates better result	1 month
Secondary	Neurofilament light chain (NfL)	Higher indicates better result	1 month
Secondary	BDNF	Higher indicates better result	1 month
Secondary	Platelet-derived growth factor receptor beta (PDGFRß)	Higher indicates better result	1 month
Secondary	Clusterin	Higher indicates better result	1 month
Secondary	GFAP	Higher indicates better result	1 month
Secondary	UCH-L1	Higher indicates better result	1 month