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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252410901 | Other Grant/Funding Number | Department of Defense, USAMRAA | |
| CDMRP-PD230100 | Other Grant/Funding Number | CDMRP-Proposal Log Number |
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The PD-HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support hemodynamic management in people with typical and atypical Parkinson's Disease, who suffer from orthostatic hypotension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | All participants will be provided with the ARC-IM Investigational System (implantable and non-implan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC-IM Investigational System | Device | Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of (serious) adverse device effects of the ARC-IM Therapy from baseline up to the end of the study. | Evaluate the safety of ARC-IM Therapy in supporting hemodynamic management in participants with atypical or typical Parkinson's Disease and orthostatic hypotension | Throughout the study (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 10-minute, orthostatic head-up tilt test with and without the ARC-IM Therapy at 1 month after intervention | Preliminary and long-term efficacy of the ARC-IM Therapy to reduce orthostatic hypotension. Measurement tool: Drop in blood pressure over time (mmHg and sec, mmHg/sec) | At the end of, 6 months after and 1 year after configuration of the therapy, |
| Measure | Description | Time Frame |
|---|---|---|
| Doppler ultrasound to measure cerebral blood perfusion with and without the ARC-IM Therapy | 1 month, 6 months and 12 months post-therapy configuration | |
| Supine hypertension will be evaluated during orthostatic tilt tests without the ARC-IM Therapy | Measurement tool: blood pressure (mmHg) during supine position of orthostatic tilt test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregoire Courtine, PhD | Contact | +41 21 69 30762 | gregoire.courtine@epfl.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jocelyne Bloch, MD | CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUV | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| Severity of symptoms measured by The Orthostatic Hypotension Questionnaire. | This outcome measures the preliminary long-term efficacy of the ARC-IM Therapy to support hemodynamic instability. The Orthostatic Hypotension Questionnaire (OHQ) has 10 hypotension symptom-related items rated on a 11 point scale (0 - 10). Measurement tool: 0 indicates no symptoms and 10 indicates worst possible severity/outcome. A higher total score indicates worse symptomatology. | At the end of, 6 months after and 1 year after configuration of the therapy |
| Time Up and Go Test (TUG) | Preliminary efficacy of the ARC-IM Therapy to improve physical activity. The Time Up and Go will measure time from sit to stand and gait quality. Measurement tool: time (sec) | At the end of, 6 months after and 1 year after configuration of the therapy |
| 2 Minute Walk Test | Preliminary efficacy of the ARC-IM Therapy to improve physical activity. The 2 Minute Walk Test (2MWT) will measure gait endurance and distance walked over 2 minutes. Measurement tool: distance (meters) | At the end of, 6 months after and 1 year after configuration of the therapy |
| Berg Balance Test | The Berg Balance Test measures the ability to balance safely with 14 specific tasks performed while standing, sitting, or making simple movements. The test scoring ranges from 0 to 56. Measurement tool: lower score indicates greater risk of losing your balance. | At the end of, 6 months after and 1 year after configuration of the therapy |
| Quebec User Evaluation of Satisfaction with technology (QUEST 2.0) | To measure the usability of the ARC-IM Main Controller, Clinician Programmer, and Personal Programmer for clinicians and participants. The Quebec User Evaluation of Satisfaction with technology (QUEST 2.0) is a 12-item instrument that evaluates satisfaction with the therapy across form factor, safety, durability, simplicity of use, comfort, service of device and improvements. The evaluation will be performed by a moderator with the participant. Measurement tool: Total score from 12 to 60. Low score means a better outcome. | At 6 months and 1 year after configuration of the therapy |
| System Usability Scale (SUS) | Assess the usability of the ARC-IM Main Controller, Clinician Programmer, and Personal Programmer for clinicians and participants. The System Usability Scale (SUS) is a 10-item scale that evaluates the usability and satisfaction of the technology. Measurement tool: Total score from 0 to 100. Higher score indicates better outcome. | At 6 months and 1 year after configuration of the therapy |
| Additional user feedback of ARC-IM System | To assess the usability of the ARC-IM Main Controller, Clinician Programmer, and Personal Programmer for clinicians and participants. The Additional user feedback of ARC-IM System is a custom-made user feedback questionnaire to evaluate the overall satisfaction of specific aspects of the therapy including battery life, device communication etc. Measurement tool: Total score where applicable (higher score indicates better outcome) and feedback from participants | At 6 months and 1 year after configuration of the therapy |
| 1 month, 6 months and 12 months post-therapy configuration |
| MDS-sponsored Unified Parkinson's Disease Rating Scale Part IB & II | Participants' quality of life will be assessed with MDS-sponsored Unified Parkinson's Disease Rating Scale Part IB & II to measure sleep, mental health, and fatigue (MDS-UPDRS-IB & II) over 20 items. Measurement tool: Total score (0 - 4 rating per question), 0 represents no impairment and 4 represents severe impairment. Higher total score indicates worse symptoms. | 1 month, 6 months and 12 months post-therapy configuration |
| King's Parkinson's Disease Pain Scale | Participants' quality of life will be assessed with the 7-item King's Parkinson's Disease Pain Scale to characterize severity and types of pain associated with Parkinson's Disease. Measurement tool: Total score from 0 to 168. Lower score indicates a better outcome. | 1 month, 6 months and 12 months post-therapy configuration |
| Parkinson's Disease Questionnaire-39 (PDQ-39) | Participants' quality of life will be measured by the 39 item Parkinson's Disease Questionnaire-39 (PDQ-39) to evaluate perceived health in terms of physical, mental and social functions. Measurement tool: Total score from 0-100, higher scores reflect lower quality of life | 1 month, 6 months and 12 months post-therapy configuration |
| Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction | Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction (SCOPA-AUT) is a 25-item, self-completed questionnaire to evaluate autonomic symptoms in people with typical and atypical Parkinson's Disease. Measurement tool: Total score from 0-69 where a higher score indicates increased frequency of autonomic dysfunction symptoms | 1 month, 6 months and 12 months post-therapy configuration |
| MDS sponsored Unified Parkinson's Disease Rating Scale Part III | Participants' quality of life will be assessed with the MDS-sponsored Unified Parkinson's Disease Rating Scale Part III (19 items) to evaluate motor function. Measurement tool: Total score from 0 to 132. Low score means a better outcome. | Baseline (before surgery), and 1 month, 6 months and 12 months post-therapy configuration |
| 24 hour ambulatory measurements | Participant's quality of life will be evaluated with 24 hour blood pressure measurements with and without the therapy. Measurement tool: blood pressure (mmHg) | Baseline (before surgery), and 1 month, 6 months and 12 months post-therapy configuration |
| Closed-loop stimulation on management of hemodynamics will be measured with the change in blood pressure during 10 minute, head up tilt tests. | Closed-loop stimulation will receive feedback from a blood pressure sensor to automatically adjust stimulation intensity. We will evaluate the effects of this stimulation on management of hemodynamics during configuration sessions with pre-configured stimulations, with closed-loop stimulation and without stimulation. The feasibility and effectiveness will be measured by the drop in blood pressure (mmHg) during 10 minute, orthostatic, head-up tilt tests. | Post-operative configuration phases, through year 1 of the study |
| Time Up and Go Test across different therapeutic conditions | The complementarity of the ARC-IM Therapy with standard therapies (e.g LDopa) will be assessed over the trajectory of therapy intake with and without stimulation during configuration phases with the Time Up and Go will measure time from sit to stand and gait quality. Measurement tool: time (sec) | Post-operative configuration phases, through year 1 of the study |
| 2 Minute Walk Test across different therapeutic conditions | The complementarity of the ARC-IM Therapy with standard therapies (e.g LDopa) will be assessed over the trajectory of therapy intake with and without stimulation during configuration phases with the The 2 Minute Walk Test (2MWT) will measure gait endurance and distance walked over 2 minutes. Measurement tool: distance (meters) | Post-operative configuration phases, through year 1 of the study |
| Berg Balance Test across different therapeutic conditions | The complementarity of the ARC-IM Therapy with standard therapies (e.g LDopa) will be assessed over the trajectory of therapy intake with and without stimulation during configuration phases with the Berg Balance Test measures the ability to balance safely with 14 specific tasks performed while standing, sitting, or making simple movements. Measurement tool: Total score from 0-56, lower score indicates greater risk of losing your balance. | Post-operative configuration phases, through year 1 of the study |
| Montréal Cognitive Assessment (MoCA) | To objectively characterize and longitudinally monitor cognitive status over the course of the study, the Montréal Cognitive Assessment (MoCA) will be performed. This assessment evaluates several cognitive domains including attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation and orientation. Measurement tool: Total score (0-30), with higher scores indicating better cognitive function. | Baseline, 1 month, 6 months and 12 months post-therapy configuration |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D012791 | Shy-Drager Syndrome |
| C537381 | Multiple system atrophy (MSA) with orthostatic hypotension |
| D007024 | Hypotension, Orthostatic |
| D054970 | Pure Autonomic Failure |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019578 | Multiple System Atrophy |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D054971 | Orthostatic Intolerance |
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