Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease (NCT06798844)

Trial Overview

Trial Overview

| Field | Value |
|-------|-------|
| NCT ID | NCT06798844 |
| Trial Name | Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease (SCSforFOG) |
| Status | RECRUITING |
| Phase | Phase 2 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Start Date | 2025 |
| Enrollment | 29 participants (estimated) |
| Study Type | Interventional |
| Design | Sham-controlled, randomized, double-blinded, crossover trial |
| Device | Medtronic Inceptiv neurostimulator |

Study Description

Freezing of gait (FOG) is one of the most disabling symptoms in Parkinson's disease (PD), characterized by transient episodes where patients feel their feet are glued to the floor, leading to falls, reduced mobility, and significantly impaired quality of life. While dopaminergic medications and deep brain stimulation (DBS) effectively address many motor symptoms, FOG often remains refractory to these treatments.

Spinal cord stimulation (SCS) has emerged as a promising neuromodulation approach for FOG. Unlike DBS, which targets deep brain structures, SCS modulates sensory and motor circuits in the spinal cord, potentially addressing the gait and balance dysfunction that characterizes FOG. This trial at KU Leuven, a leading European center for movement disorders and neuromodulation research, will evaluate the efficacy of SCS for treating FOG in Parkinson's disease patients who have persistent freezing despite optimized medical management or DBS.

Background

Freezing of Gait in Parkinson's Disease

FOG is a complex phenomenon that affects approximately 50-60% of PD patients during disease progression. Key characteristics include:

• Transient motor blocks: Brief episodes where voluntary gait initiation or continuation fails
• Shuffling gait: Short, rapid steps with decreased stride length
• Turn-to-turn freezing: Particular difficulty when changing direction
• Trigger factors: Narrow spaces, doorways, stress, dual-tasking

• Increased fall risk and fear of falling
• Reduced independence and quality of life
• Poor response to dopaminergic medications
• Often persists despite DBS targeting the subthalamic nucleus or globus pallidus internus

Spinal Cord Stimulation for Movement Disorders

SCS has been used for decades to treat chronic pain, but recent research has expanded its application to movement disorders. The mechanism involves:

Prior Evidence

Previous studies have demonstrated that SCS can improve gait and balance in PD patients:

• Thoracic SCS has shown efficacy for gait dysfunction and FOG in several small trials
• Improvements in stride length, gait velocity, and postural stability have been reported
• The Medtronic Inceptiv is a next-generation rechargeable neurostimulator with enhanced sensing capabilities

Trial Design

Study Structure

This is a sham-controlled, randomized, double-blinded, crossover trial. This design minimizes bias and allows each patient to serve as their own control:

| Phase | Description | Duration |
|-------|-------------|----------|
| Screening | Assessment of eligibility | 4 weeks |
| randomization | Active vs sham assignment | Day 0 |
| Active/Sham Period 1 | First treatment period | 12 weeks |
| Washout | Transition period | 4 weeks |
| Active/Sham Period 2 | Crossover treatment period | 12 weeks |
| Follow-up | Long-term assessment | 4 weeks |

Intervention Details

Device: Medtronic Inceptiv neurostimulator (SCS system)

Stimulation Parameters:

• High-frequency stimulation (tested at multiple frequencies)
• Standard polarity configuration
• Individualized programming based on patient response

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Outcome Measures

Primary Outcomes

| Measure | Description | Timepoints |
|---------|-------------|------------|
| Freezing of Gait Questionnaire (FOG-Q) | Self-reported FOG severity and frequency | Baseline, 12 weeks, 24 weeks |
| Gait velocity | Timed 10-meter walk test | Baseline, 12 weeks, 24 weeks |
| Step length | Measured via walkway system | Baseline, 12 weeks, 24 weeks |

Secondary Outcomes

| Measure | Description | Timepoints |
|---------|-------------|------------|
| MDS-UPDRS Part III | Motor examination score | Baseline, 12 weeks, 24 weeks |
| Timed Up and Go (TUG) | Functional mobility | Baseline, 12 weeks, 24 weeks |
| Freezing of Gait Questionnaire (FOG-Q) subscales | Subscale analysis | Baseline, 12 weeks, 24 weeks |
| Gait variability metrics | Stride time variability, step length variability | Baseline, 12 weeks, 24 weeks |
| Quality of Life (PDQ-39) | Parkinson's Disease Questionnaire | Baseline, 12 weeks, 24 weeks |
| Falls frequency | Number of falls per period | Throughout study |
| Safety assessment | Adverse events monitoring | Continuous |

Location

• Site: University Hospitals Leuven (UZ Leuven)
• City: Leuven, Belgium
• Country: Belgium
• Principal Investigator: To be confirmed

Scientific Rationale

Why Spinal Cord Stimulation?

SCS offers several potential advantages over other neuromodulation approaches for FOG:

Mechanism of Action for FOG

The theoretical basis for SCS in FOG includes:

Comparison to Other FOG Treatments

| Treatment | Mechanism | Efficacy for FOG | Invasiveness |
|-----------|-----------|-----------------|--------------|
| SCS (this trial) | Spinal neuromodulation | Under investigation | Moderate (epidural) |
| DBS (STN/GPI) | Deep brain stimulation | Partial response | High (intracranial) |
| Levodopa | Dopamine replacement | Limited for FOG | Non-invasive |
| Physical therapy | Gait training | Moderate | Non-invasive |
| Cueing devices | Sensory cueing | Moderate | Non-invasive |

Risks and Safety Considerations

Device-Related Risks

• Infection (3-5%)
• Lead migration or fracture (10-15%)
• Battery depletion
• Skin erosion over implanted hardware

Stimulation-Related Effects

• Uncomfortable paresthesia
• Muscle cramping
• Autonomic effects (rare)
• Tolerance requiring parameter adjustment

Surgical Risks

• Spinal cord injury (<1%)
• Dural puncture
• Cerebrospinal fluid leak
• Hemorrhage

PD-Specific Considerations

• Potential interaction with dopaminergic medications
• Possible impact on dyskinesias
• Need for careful programming

KU Leuven Research Program

University Hospitals Leuven is a leading European center for movement disorder research, particularly in neuromodulation:

• History: Pioneered advanced DBS programming and targeting
• Expertise: Comprehensive program including DBS, SCS, and other neuromodulation approaches
• Infrastructure: State-of-the-art gait laboratories and neuroimaging facilities

Future Implications

If successful, this trial could:

Related Pages

• [Parkinson's Disease](/diseases/parkinsons-disease)](/proteins/parkin)
• [Freezing of Gait](/diseases/parkinson-disease#freezing-of-gait)](/proteins/parkin)
• [Spinal Cord Stimulation for Parkinson's Disease](/therapeutics/spinal-cord-stimulation-parkinsons)](/therapeutics)
• [Deep Brain Stimulation for PD](/therapeutics/deep-brain-stimulation-pd)](/therapeutics)
• [Neuromodulation Technologies](/therapeutics/neurostimulation)](/technologies)
• [Thoracic Epidural SCS for PD FOG (NCT06630702)](clinical-trials/nct06630702)

External Links

• [ClinicalTrials.gov: NCT06798844](https://clinicaltrials.gov/study/NCT06798844)
• [KU Leuven Hospital](https://www.uzleuven.be/)
• [Parkinson's Foundation](https://www.parkinson.org/)

References

Pathway Diagram

The following diagram shows the key molecular relationships involving Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease (NCT06798844) discovered through SciDEX knowledge graph analysis: