Trial of Four Spinal Cord Stimulation Paradigms for Gait Impairment in Parkinson's Disease

June 16, 2026 updated by: University of Aarhus

Cross-over Trial of Four Spinal Cord Stimulation Paradigms for Gait Impairment in Parkinson's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants who completed the open extension phase of STEP-PD and still had SCS

Exclusion Criteria:

  • MoCA <23

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High frequency/low pulse width
Other: Stimulation paradigm: High frequency / low pulse width
High frequency/low pulse width (300 Hz/90 μsec)
Active Comparator: Low frequency/high pulse width
Other: Stimulation paradigm: Low frequency / high pulse width
Low frequency/high pulse width (130 Hz/300 μsec)
Active Comparator: Fast-Acting Sub-perception Therapy
Other: Fast Acting Sub-perception Therapy
FAST
Active Comparator: MicroBurst
Other: MicroBurst
MicroBurst stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural Instability / Gait Difficulty
Time Frame: From enrollment to the end of the study at eight months.
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
Time Frame: From enrollment to the end of the study at eight months.
MDS-UPDRS subscore (ranging 0-36). Higher score is worse.
From enrollment to the end of the study at eight months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change
Time Frame: From enrolment to the end of the study at eight months.
Ranging 0-6. Higher score is better.
From enrolment to the end of the study at eight months.
New Freezing of Gait Questionnaire
Time Frame: From enrolment to the end of the study at eight months.
The Danish version ranging 0-30. Higher score is worse.
From enrolment to the end of the study at eight months.
Active Balance and Confidence scale
Time Frame: From enrolment to the end of the study at eight months.
Range 0-100, higher score is better.
From enrolment to the end of the study at eight months.
Parkinson's Disease Questionnaire - 39
Time Frame: From enrolment to the end of the study at eight months.
Score range from 0-100, higher score is worse.
From enrolment to the end of the study at eight months.
Berg Balance Scale
Time Frame: From enrolment to the end of the study at eight months.
Higher score is better (range 0-56). Total scores below 41 indicate moderate falls risk.
From enrolment to the end of the study at eight months.
Gait assessments
Time Frame: From enrolment to the end of the study at eight months.
Timed TUG, DT, 20-metres walks, and mean figure-of-eight test. Longer time is worse.
From enrolment to the end of the study at eight months.
Number of falls
Time Frame: From enrolment to the end of the study at eight months.
Reported since last visit. Higher number is worse.
From enrolment to the end of the study at eight months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Danish Council for Independent Research
Danish Parkinson Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

June 12, 2025

Study Completion (Actual)

June 12, 2025

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCS Settings

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual data for all outcomes will be provided in Supplementary Materials.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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