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Completed

NCT Number: NCT07659405

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.

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Key information

Conditions

Parkinson's Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Spinal Cord Stimulation (SCS) Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • MoCA <23

Treatment and study plan

Stimulation paradigm: High frequency / low pulse width

Other

High frequency/low pulse width (300 Hz/90 μsec)

Stimulation paradigm: Low frequency / high pulse width

Other

Low frequency/high pulse width (130 Hz/300 μsec)

Microburst

Other

MicroBurst stimulation

Fast Acting Sub-perception Therapy

Other

FAST

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Number of falls

    Time frame: From enrolment to the end of the study at eight months.

    Reported since last visit. Higher number is worse.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Danish Council for Independent Research
  • Danish Parkinson Association

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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