Parkinson's Disease (PD)NCT07659405
Trial of Four Spinal Cord Stimulation Paradigms for Gait Impairment in Parkinson's Disease
A study testing Stimulation paradigm: High frequency / low pulse width, Stimulation paradigm: Low frequency / high pulse width and MicroBurst in people with Parkinson's Disease (PD) and Spinal Cord Stimulation (SCS), run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease (PD), Spinal Cord Stimulation (SCS)
- What is being tested?
- Stimulation paradigm: High frequency / low pulse width, Stimulation paradigm: Low frequency / high pulse width and MicroBurst
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2023to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants who completed the open extension phase of STEP-PD and still had SCS
Who cannot join
- MoCA <23
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Stimulation paradigm: High frequency / low pulse width, Stimulation paradigm: Low frequency / high pulse width, MicroBurst, Fast Acting Sub-perception Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation paradigm: High frequency / low pulse widthOther
High frequency/low pulse width (300 Hz/90 μsec)
Stimulation paradigm: Low frequency / high pulse widthOther
Low frequency/high pulse width (130 Hz/300 μsec)
MicroBurstOther
MicroBurst stimulation
Fast Acting Sub-perception TherapyOther
FAST
| Study group | Role | What they receive |
|---|---|---|
| High frequency/low pulse width | Active comparator | Not described Receives: Other: Stimulation paradigm: High frequency / low pulse width |
| Low frequency/high pulse width | Active comparator | Not described Receives: Other: Stimulation paradigm: Low frequency / high pulse width |
| Fast-Acting Sub-perception Therapy | Active comparator | Not described Receives: Other: Fast Acting Sub-perception Therapy |
| MicroBurst | Active comparator | Not described Receives: Other: MicroBurst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Instability / Gait Difficulty
MDS-UPDRS subscore (ranging 0-20). Higher score is worse.
Measured: 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.
Measured: From enrollment to the end of the study at eight months.
Secondary outcomes (7)
Patient Global Impression of Change
Ranging 0-6. Higher score is better.
Measured: From enrolment to the end of the study at eight months.
New Freezing of Gait Questionnaire
The Danish version ranging 0-30. Higher score is worse.
Measured: From enrolment to the end of the study at eight months.
Active Balance and Confidence scale
Range 0-100, higher score is better.
Measured: From enrolment to the end of the study at eight months.
Parkinson's Disease Questionnaire - 39
Score range from 0-100, higher score is worse.
Measured: From enrolment to the end of the study at eight months.
Berg Balance Scale
Higher score is better (range 0-56). Total scores below 41 indicate moderate falls risk.
Measured: From enrolment to the end of the study at eight months.
Gait assessments
Timed TUG, DT, 20-metres walks, and mean figure-of-eight test. Longer time is worse.
Measured: From enrolment to the end of the study at eight months.
Number of falls
Reported since last visit. Higher number is worse.
Measured: From enrolment to the end of the study at eight months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jun 2023
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Parkinson Association, Danish Council for Independent Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659405
- Sponsor's protocol ID
- SCS Settings
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual data for all outcomes will be provided in Supplementary Materials.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over Trial of Four Spinal Cord Stimulation Paradigms for Gait Impairment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07659405
- Acronym / sponsor ID
- SCS Settings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Parkinson Association, Danish Council for Independent Research
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High frequency/low pulse width | Active comparator | Other: Stimulation paradigm: High frequency / low pulse width |
| Low frequency/high pulse width | Active comparator | Other: Stimulation paradigm: Low frequency / high pulse width |
| Fast-Acting Sub-perception Therapy | Active comparator | Other: Fast Acting Sub-perception Therapy |
| MicroBurst | Active comparator | Other: MicroBurst |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who completed the open extension phase of STEP-PD and still had SCS
Key exclusion criteria (1 listed)
- MoCA <23
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation paradigm: High frequency / low pulse widthHigh frequency/low pulse width (300 Hz/90 μsec) | Other | High frequency/low pulse width |
| Stimulation paradigm: Low frequency / high pulse widthLow frequency/high pulse width (130 Hz/300 μsec) | Other | Low frequency/high pulse width |
| MicroBurstMicroBurst stimulation | Other | MicroBurst |
| Fast Acting Sub-perception TherapyFAST | Other | Fast-Acting Sub-perception Therapy |
Primary outcome
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.
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.
7 secondary outcomes
Patient Global Impression of Change
Time frame: 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.
Active Balance and Confidence scale
Time frame: 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.
Berg Balance Scale
Time frame: 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.
Number of falls
Time frame: From enrolment to the end of the study at eight months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual data for all outcomes will be provided in Supplementary Materials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation paradigm: High frequency / low pulse width, Stimulation paradigm: Low frequency / high pulse width and MicroBurst in people with Parkinson's Disease (PD) and Spinal Cord Stimulation (SCS), run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Instability / Gait Difficulty (time frame: From enrollment to the end of the study at eight months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.