Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608875
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops in a Proof-of-principle Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StimuLOOP-PD
Brief Summary:
Parkinsons 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
StimuLOOPPD intends to foster structured and reproducible methods for precision neurorehabilitation of gait in PD The investigator will conduct a proof-of-concept study to investigate a combination of two methods that are each tailored to the individual patient Two innovative technologies are applied in concert to enhance recovery of lower limb function
1 Hyper-personalized feedback HPF For lower limb motor rehabilitation the investigator will employ real-time continuous feedback for movement aspects that are specific to each participants motor deficit The feedback will be adapted and tailored to each participant This results in a two-step personalization in a first step the investigator will choose what movement aspect is therapeutically targeted and in a second step the investigator will define how the feedback is presented to the participant
2 Targeted auditory stimulation during sleep TASSThe investigator aim to reactivate rehabilitation- related memories through the presentation of auditory stimuli during sleep with the goal of promoting motor memory consolidation into stable motor commands
The HPF intervention is expected to induce rapid adaptations which however do not persist over multiple days To counter this the investigator will leverage memory reactivation during sleep to enhance the consolidation of the movement patterns that are learned during HPF
The investigator expect that these interventions will lead to greater gains in functional walking ability Beyond demonstrating a proof-of-concept for novel methods of precision neurorehabilitation positive results of this project may have implications for neurorehabilitation treatment in general by providing first insights into the benefits and interplay of HPF and TASS
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
StimuLOOPPD intends to foster structured and reproducible methods for precision neurorehabilitation of gait in PD The investigator will conduct a proof-of-concept study to investigate a combination of two methods that are each tailored to the individual patient Two innovative technologies are applied in concert to enhance recovery of lower limb function
1 Hyper-personalized feedback HPF For lower limb motor rehabilitation the investigator will employ real-time continuous feedback for movement aspects that are specific to each participants motor deficit The feedback will be adapted and tailored to each participant This results in a two-step personalization in a first step the investigator will choose what movement aspect is therapeutically targeted and in a second step the investigator will define how the feedback is presented to the participant
2 Targeted auditory stimulation during sleep TASSThe investigator aim to reactivate rehabilitation- related memories through the presentation of auditory stimuli during sleep with the goal of promoting motor memory consolidation into stable motor commands
The HPF intervention is expected to induce rapid adaptations which however do not persist over multiple days To counter this the investigator will leverage memory reactivation during sleep to enhance the consolidation of the movement patterns that are learned during HPF
The investigator expect that these interventions will lead to greater gains in functional walking ability Beyond demonstrating a proof-of-concept for novel methods of precision neurorehabilitation positive results of this project may have implications for neurorehabilitation treatment in general by providing first insights into the benefits and interplay of HPF and TASS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None