Trial of Four Spinal Cord Stimulation Paradigms for Gait Impairment in Parkinson's Disease
Cross-over Trial of Four Spinal Cord Stimulation Paradigms for Gait Impairment in Parkinson's Disease
1 other identifier
interventional
11
1 country
1
Brief Summary
Patients with PD and SCS treatment for gait impairment entered a cross-over trial of four stimulation paradigms; high frequency/low pulse width, low frequency/high pulse width, Fast-Acting Sub-perception Therapy, and MicroBurst.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2025
CompletedFirst Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedJune 22, 2026
June 1, 2026
2 years
June 10, 2026
June 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Postural Instability / Gait Difficulty
MDS-UPDRS subscore (ranging 0-20). Higher score is worse.
From enrollment to the end of the study at eight months.
Lower Body Gait score
MDS-UPDRS subscore (ranging 0-36). Higher score is worse.
From enrollment to the end of the study at eight months.
Secondary Outcomes (7)
Patient Global Impression of Change
From enrolment to the end of the study at eight months.
New Freezing of Gait Questionnaire
From enrolment to the end of the study at eight months.
Active Balance and Confidence scale
From enrolment to the end of the study at eight months.
Parkinson's Disease Questionnaire - 39
From enrolment to the end of the study at eight months.
Berg Balance Scale
From enrolment to the end of the study at eight months.
- +2 more secondary outcomes
Study Arms (4)
High frequency/low pulse width
ACTIVE COMPARATORLow frequency/high pulse width
ACTIVE COMPARATORFast-Acting Sub-perception Therapy
ACTIVE COMPARATORMicroBurst
ACTIVE COMPARATORInterventions
High frequency/low pulse width (300 Hz/90 μsec)
Low frequency/high pulse width (130 Hz/300 μsec)
Eligibility Criteria
You may qualify if:
- Participants who completed the open extension phase of STEP-PD and still had SCS
You may not qualify if:
- MoCA \<23
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Danish Parkinson Associationcollaborator
- Danish Council for Independent Researchcollaborator
Study Sites (1)
Aarhus University
Aarhus, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2026
First Posted
June 22, 2026
Study Start
June 1, 2023
Primary Completion
June 12, 2025
Study Completion
June 12, 2025
Last Updated
June 22, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Individual data for all outcomes will be provided in Supplementary Materials.