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

NCT07082595 | Recruiting

• 2 other identifiers: StimuLOOP_PD-S2024-01941
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Parkinson disease; Sleep; Neurorehabilitation; Auditory stimulation; StimuLOOP

Outcome Measures

Primary Outcomes (2)

• functional walking ability

  the change in functional walking ability assessed with the 6-minute walk test (6MWT)

  Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).

• postural stability

  the change in postural stability assessed with the MiniBEST test measured before and after the intervention period.

  Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).

Secondary Outcomes (5)

• Phase Coordination Index

  Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).

• Continuous Relative Phase

  Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).

• Variability

  Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).

• Symmetry

  Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).

• Margin of Stability

  Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).

Study Arms (2)

Sham arm

SHAM COMPARATOR

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

Other: TASS Intervention (Sham)

Verum arm

EXPERIMENTAL

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

Other: TASS Intervention (Verum)

Interventions

TASS Intervention (Sham) 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.

Sham arm

TASS Intervention (Verum) 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.

Verum arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• ETH Zurich (Switzerland): collaborator

Study Sites (1)

University of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Christian Baumann, Prof. Dr. med.

CONTACT

+41 44 255 00 02; christian.baumann@usz.ch

Angelina Maric, Dr. phil.

CONTACT

+ 41 255 86 15; angelina.maric@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 24, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)