Trial Overview
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clinical_trials_scs_fog_pd_nct["Spinal Cord Stimulation for Freezing of Gait in"]
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clinical_trials_scs__0["Trial Overview"]
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clinical_trials_scs__1["Study Description"]
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clinical_trials_scs__2["Freezing of Gait in Parkinsons Disease"]
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clinical_trials_scs__3["Spinal Cord Stimulation for Movement Disorders"]
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clinical_trials_scs__4["Prior Evidence"]
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clinical_trials_scs__5["Trial Design"]
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...Trial Overview
Mermaid diagram (expand to render)
| 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
FOG is associated with:
- 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:
Dorsal column activation: Electrical stimulation activates large-diameter sensory fibers (A-β fibers)
Modulation of spinal motor circuits: Influences the central pattern generators for locomotion
Restoration of sensory-motor integration: Improves the feedback loops necessary for coordinated walking
Normalization of pathological oscillations: Similar to DBS, may reduce abnormal beta-band synchronizationPrior 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
Sham Control: Device implanted but not activated, maintaining blinding
Eligibility Criteria
Inclusion Criteria
Diagnosis: Idiopathic Parkinson's disease (UK Brain Bank criteria)
FOG severity: Self-reported FOG ≥1 episode per day despite optimal medical management
DBS status: Either with or without prior DBS (optimized for FOG if present)
Mobility: Able to walk 10 meters unassisted
Age: 40-79 years
Cognitive status: Adequate cognitive function (MoCA score threshold)Exclusion Criteria
Neurological conditions: Severe neurological or psychiatric disorders other than PD
SCS contraindications: Spinal pathology, coagulopathy, or other contraindications
Cognitive impairment: Significant cognitive impairment (MoCA < threshold)
Secondary Parkinsonism: Atypical Parkinsonism or drug-induced ParkinsonismOutcome 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:
Non-cerebral target: Avoids risks associated with intracranial electrode placement
Modulates spinal motor circuits: Targets the final common pathway for locomotion
Lower cognitive risk: Does not directly modulate cortical or limbic circuits
Reversible: Can be adjusted or discontinued
Established safety profile: SCS has been used for decades in pain medicineMechanism of Action for FOG
The theoretical basis for SCS in FOG includes:
Sensory gating improvement: FOG is associated with impaired sensory integration; SCS enhances proprioceptive feedback
Motor circuit normalization: Modulates the spinal cord circuits that generate rhythmic motor output
Cortical excitability changes: May reduce pathological beta-band oscillations affecting motor cortex
Reticulospinal pathway modulation: Activates descending pathways important for gait initiationComparison 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
- Infection (3-5%)
- Lead migration or fracture (10-15%)
- Battery depletion
- Skin erosion over implanted hardware
- 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
The center has contributed significantly to understanding FOG pathophysiology and developing novel therapeutic approaches.
Future Implications
If successful, this trial could:
Establish SCS as an evidence-based treatment for FOG in PD
Provide a new therapeutic option for patients with medication-refractory FOG
Advance understanding of spinal cord contributions to gait control in PD
Guide patient selection for SCS therapyRelated 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
[Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease (SCSforFOG) - NCT06798844](https://clinicaltrials.gov/study/NCT06798844)
[Spinal Cord Stimulation for Parkinson's Disease](/therapeutics/spinal-cord-stimulation-parkinsons)
[Thoracic Epidural SCS for Parkinson's Disease Freezing of Gait (NCT06630702)](clinical-trials/nct06630702)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:
Mermaid diagram (expand to render)