Personalized Stimulation Loop for Neurorehabilitation in Parkinson: a Proof-of-principle Study

NCT ID: NCT07082595

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2028-03-31

Brief Summary

Parkinson's disease (PD) is a neurodegenerative disease that affects about 1% of the elderly population and accounts for substantial disability and health care costs. Disability is largely driven by mobility deficits caused by impaired gait. Effective treatments are available to restore lower limb function and improve gait, but response to treatment varies greatly from patient to patient and often shows only small effect sizes. Addressing this heterogeneity requires personalization, a concept referred to precision neurorehabilitation.

StimuLOOP.PD-Sleep intends to foster structured and reproducible methods for precision neurorehabilitation of gait in PD. The investigators will conduct a proof-of-concept study to investigate a sleep intervention tailored to the individual patient in the context of motor rehabilitation.

• Targeted auditory stimulation during sleep (TASS): The investigators aim to reactive rehabilitation-related memories through presentation of auditory stimuli during sleep with the goal of promoting motor memory consolidation into stable motor commands.

The investigators will leverage TASS to enhance consolidation of the movement patterns that are learned during rehabilitation.

The investigators expect that this intervention will lead to greater gains in functional walking ability and balance. Beyond demonstrating a proof-of-concept for novel methods of applying TASS stimulation in the context of neurorehabilitation, positive results of this project may have implications for neurorehabilitation treatment in general by providing first insights into the benefits and interplay of TASS with a rehabilitation.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sham arm

Control targeted auditory stimulation during sleep during motor rehabilitation (TASS sham intervention)

Group Type: SHAM_COMPARATOR

TASS Intervention (Sham)

Intervention Type: OTHER

Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. No auditory stimuli will be delivered.

Verum arm

Targeted auditory stimulation during sleep during motor rehabilitation (TASS verum intervention)

Group Type: EXPERIMENTAL

TASS Intervention (Verum)

Intervention Type: OTHER

TASS: Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. Auditory stimuli will be delivered through the integrated headphones when non-rapid-eye-movement (NREM) sleep is detected during the night to induce TASS.

Interventions

TASS Intervention (Sham)

Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. No auditory stimuli will be delivered.

Intervention Type: OTHER

TASS Intervention (Verum)

TASS: Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. Auditory stimuli will be delivered through the integrated headphones when non-rapid-eye-movement (NREM) sleep is detected during the night to induce TASS.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Idiopathic Parkinson's disease with gait and postural stability deficits
• ≥18 years of age
• UPDRS III gait scores 1-3
• UPDRS III postural instability scores 1-3
• Prescribed rehabilitation therapy
• Informed consent as documented by signature
• Adjustments in dopaminergic medication and DBS stimulation to improve

Exclusion Criteria

• Cognitive impairment, Montreal Cognitive Assessment (MoCa) < 20
• Other neurological or medical condition that caused sustained clinically relevant gait and/or postural stability deficits
• History of a physical or neurological condition that interferes with study procedures
• Social and/or personal circumstances that interfere with the ability to return for assessments
• Patients taking benzodiazepines or Z-drugs that have a significant effect on sleep EEG
• Recent DBS implant (≤ 6 months)
• Inability to perform outcome assessments without walking aid
• Skin disorders/problems/allergies in face/ear area that could worsen with electrode application (e.g. nickel allergy)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ETH Zurich (Switzerland)

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Zurich

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Christian Baumann, Prof. Dr. med.

Role: CONTACT

christian.baumann@usz.ch

+41 44 255 00 02

Angelina Maric, Dr. phil.

Role: CONTACT

angelina.maric@usz.ch

+ 41 255 86 15

Facility Contacts

Angelina Maric, Dr. phil.

Role: primary

angelina.maric@usz.ch

+41 255 86 15

Yannik Rottenberger, MSc

Role: backup

yannik.rottenberger@usz.ch

+41 255 56 45

Other Identifiers

2024-01941

Identifier Type: OTHER

Identifier Source: secondary_id

StimuLOOP_PD-S

Identifier Type: -

Identifier Source: org_study_id