Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295614
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-20
Brief Title:
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinsons Disease
Sponsor:
Ecole Polytechnique Fédérale de Lausanne
Organization:
Ecole Polytechnique Fédérale de Lausanne
Study Overview
Official Title:
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARKL
Brief Summary:
The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinsons disease The ARC-IM Therapy employs epidural electrical stimulation EES to modulate leg muscle recruitment with the aim of improving mobility deficits The ultimate goal is to enhance the quality of life of people with Parkinsons disease
Detailed Description:
The progression of Parkinsons Disease PD is often marked by the development of severe locomotor deficits including gait impairments which significantly affect patients independence and are not effectively addressed by current treatments The STIMO-PARKINSON NCT04956770 clinical trial has shown promising results with epidural electrical stimulation EES in significantly reducing these locomotor deficits in Parkinsons Disease patients
Building on these findings the SPARKL clinical study aims to further this research The SPARKL study aims to enroll six individuals with advanced Parkinsons Disease to assess the safety and efficacy of the novel ARC-IM Therapy This new therapy has been designed to overcome previous technological limitations and facilitate its home-use
This study will take place at the Lausanne University Hospital CHUV Switzerland The total duration of the study is 4 years per participant The study intervention consists of several phases preceded by pre-screening The first year involves an intensive participation consisting of the following phases enrolment and baseline surgical implantation of the stimulation device a main study phase that includes stimulation configuration sessions and both in-clinic and at-home rehabilitation and finally the home-use phase This will be succeeded by 3 years of safety follow-up during which the participant can use the stimulation device in their daily life subject to investigator approval
Throughout the study the investigators will conduct assessments at various stages of each participants journey in the study These assessments will be used to assess the preliminary safety and efficacy of the ARC-IM therapy at alleviating locomotor deficits
Building on these findings the SPARKL clinical study aims to further this research The SPARKL study aims to enroll six individuals with advanced Parkinsons Disease to assess the safety and efficacy of the novel ARC-IM Therapy This new therapy has been designed to overcome previous technological limitations and facilitate its home-use
This study will take place at the Lausanne University Hospital CHUV Switzerland The total duration of the study is 4 years per participant The study intervention consists of several phases preceded by pre-screening The first year involves an intensive participation consisting of the following phases enrolment and baseline surgical implantation of the stimulation device a main study phase that includes stimulation configuration sessions and both in-clinic and at-home rehabilitation and finally the home-use phase This will be succeeded by 3 years of safety follow-up during which the participant can use the stimulation device in their daily life subject to investigator approval
Throughout the study the investigators will conduct assessments at various stages of each participants journey in the study These assessments will be used to assess the preliminary safety and efficacy of the ARC-IM therapy at alleviating locomotor deficits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None