Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-01941 | Other Identifier | BASEC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ETH Zurich (Switzerland) | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham arm | Sham Comparator | Control targeted auditory stimulation during sleep during motor rehabilitation (TASS sham intervention) |
|
| Verum arm | Experimental | Targeted auditory stimulation during sleep during motor rehabilitation (TASS verum intervention) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Coordination Index | Motor learning assessed via changes in coordination. Coordination assessed using the 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
Motor learning assessed via changes in coordination. Coordination assessed using Continous 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 | 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. | Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment). |
| Symmetry | Motor learning assessed via changes in symmetry. Symmetry (%) in step length and step time. | 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 | Motor learning assessed via changes in stability. Stability assessed using 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). |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |