| 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 |
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.
FOG is a complex phenomenon that affects approximately 50-60% of PD patients during disease progression. Key characteristics include:
FOG is associated with:
SCS has been used for decades to treat chronic pain, but recent research has expanded its application to movement disorders. The mechanism involves:
Previous studies have demonstrated that SCS can improve gait and balance in PD patients:
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 |
Device: Medtronic Inceptiv neurostimulator (SCS system)
Stimulation Parameters:
Sham Control: Device implanted but not activated, maintaining blinding
| 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 |
| 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 |
SCS offers several potential advantages over other neuromodulation approaches for FOG:
The theoretical basis for SCS in FOG includes:
| 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 |
University Hospitals Leuven is a leading European center for movement disorder research, particularly in neuromodulation:
The center has contributed significantly to understanding FOG pathophysiology and developing novel therapeutic approaches.
If successful, this trial could: