Study Rationale:
Freezing of gait (FOG) is one of the most disabling symptoms of Parkinson’s disease. People with FOG may suddenly feel like their feet are “stuck” to the ground, especially when turning, walking through doorways, or under pressure. This symptom often does not improve with Parkinson’s medication or with typical deep brain stimulation (DBS). A small region deep in the brain called the cuneiform nucleus (CnF) plays a key role in starting and stopping walking. Our team recently completed a pilot study that showed that targeting this region with directional DBS may help reduce FOG. This new clinical trial will build on that success to further test this approach.
Hypothesis:
Stimulating the cuneiform nucleus using advanced sensing-enabled DBS will safely reduce freezing of gait in people with Parkinson’s disease who have not responded to medication.
Study Design:
We will enroll 18 participants across three medical centers. All participants will undergo DBS surgery targeting the cuneiform nucleus. For the first 2 months after surgery, half of the participants will have the stimulator turned on and half will have it off, without knowing which. After two months, everyone will receive active stimulation. Throughout the study, we will use walking tests, wearable sensors, and brain signal recordings to measure changes in mobility and brain activity. We will also collect feedback on mood, quality of life, and any side effects.
Impact on Diagnosis/Treatment of Parkinson’s Disease:
If successful, this study could lead to a new DBS target for patients with freezing of gait that does not improve with medication—offering a new treatment option where none currently exists.
Next Steps for Development:
If this trial confirms safety and benefit, we plan to expand to a larger, multi-center clinical trial and pursue FDA approval to make this therapy widely available.
Trial Phase:
Phase 1/2 (safety, feasibility, and early benefit testing)