NCT Number: NCT07082595
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Zurich, Canton of Zurich, 8091, Switzerland
Location status: Recruiting
Angelina Maric, Dr. phil.
CONTACT
Angelina Maric, Dr. phil.
PRINCIPAL_INVESTIGATOR
William R. Taylor, Prof. Dr.
PRINCIPAL_INVESTIGATOR
Yannik Rottenberger, MSc
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: 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.
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)
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.
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.
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.
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.
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.
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
Contact information is provided by the study sponsor or research team.
Angelina Maric, Dr. phil.
CONTACT
Christian Baumann, Prof. Dr. med.
CONTACT
University of Zurich
Other
Acronym: StimuLOOP_PD-S
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