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NCT Number: NCT07082595

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. functional walking ability

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

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

  2. postural stability

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

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

Secondary outcomes

  1. Phase Coordination Index

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

    Motor learning assessed via changes in coordination. Coordination assessed using the Phase Coordination Index.

  2. Continuous Relative Phase

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

    Motor learning assessed via changes in coordination. Coordination assessed using Continous Relative Phase.

  3. Variability

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

    Motor learning assessed via changes in variability. Variability assessed using the coefficient of variation (%CV) of common spatio-temporal gait parameters, including stride time, stride length, step length, swing time, stance time, step width, and double limb support time.

  4. Symmetry

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

    Motor learning assessed via changes in symmetry. Symmetry (%) in step length and step time.

  5. Margin of Stability

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

    Motor learning assessed via changes in stability. Stability assessed using Margin of Stability

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • ETH Zurich (Switzerland)

Registry information

Acronym: StimuLOOP_PD-S

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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