---
title: Reduce freezing episodes during walking
nct_id: NCT06316232
phase: PHASE4
status: RECRUITING
sponsor: IRCCS Istituto delle Scienze Neurologiche di Bologna
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06316232"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06316232"
last_fetched: "2026-05-10T14:03:55.218Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce freezing episodes during walking

**Goal (in five words):** Reduce freezing episodes during walking

**Official Title:** Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study

**Trial ID:** [NCT06316232](https://clinicaltrials.gov/study/NCT06316232)

## Key Facts

- **Phase:** PHASE4
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** IRCCS Istituto delle Scienze Neurologiche di Bologna
- **Target Enrollment:** 20 participants
- **Start Date:** 2023-10-10
- **Completion Date:** 2026-12-31
- **Conditions:** Freezing of Gait, Parkinson Disease
- **Interventions:** STIM ON plus, MED ON plus
- **Intervention Types:** DEVICE, DRUG

## Summary For Families

The goal is to see whether increasing subthalamic nucleus deep brain stimulation or increasing levodopa better reduces freezing of gait that persists even when other Parkinson's motor symptoms are well controlled. One approach, called STIM ON plus, raises the electrical stimulation to the subthalamic nucleus to directly modulate the abnormal motor circuits, while the MED ON plus approach raises levodopa to boost brain dopamine; DBS changes circuit activity without adding medication, and levodopa can improve movement but may increase dyskinesias or hallucinations in some people. The trial is looking for adults 18 to 80 who already have STN-DBS with good control of tremor, rigidity and bradykinesia but who still have daily ON-state freezing by the New Freezing of Gait Questionnaire, and it excludes people who cannot walk 10 meters independently, who cannot safely increase stimulation or levodopa because of prior severe side effects, or who have dementia (MMSE ≤18).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* Patients with Parkinson's disease treated with STN-DBS who achieved a good control of motor fluctuations and cardinal motor symptoms (bradykinesia, rigidity, tremor)
* History of FoG in daily-ON condition after optimal DBS programming, defined by a score of 1 on Question 1 and score ≥ 2 on Question 2 of the New Freezing of Gait Questionnaire.

Exclusion Criteria:

* inability to walk independently for 10 meters.
* limited therapeutic windows of stimulation without the possibility of increase the intensity of stimulation of 0,5 mA for the appearance of side effects
* previous evidence of severe adverse effects with high levodopa dose ore increased STN-DBS intensity, such as psychosis, hallucinations, painful dyskinesias, severe hypotension, digestive symptoms.
* dementia (MMSE score ≤ 18)
```

## Locations (1)

- IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy _(44.4938, 11.3387)_
  - Ilaria Cani — (CONTACT) — 0039 051 4966959 — ilaria.cani@studio.unibo.it
  - Giulia Giannini — (CONTACT) — 0039 051 4966959 — giulia.giannini15@unibo.it
  - Giovanna Calandra Buonaura, MD, PhD — (SUB_INVESTIGATOR)
  - Ilaria Cani, MD — (SUB_INVESTIGATOR)
  - Carlo Alberto Artusi, MD, PhD — (SUB_INVESTIGATOR)
  - Giulia Giannini, MD, PhD — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Ilaria Cani — (CONTACT) — 0039 051 4966959 — ilaria.cani@studio.unibo.it
- Giulia Giannini — (CONTACT) — 0039 051 4966959 — giulia.giannini15@unibo.it

---

*Canonical: https://parkinsonspathways.com/trial/NCT06316232*  
*HTML version: https://parkinsonspathways.com/trial/NCT06316232*  
*Source data: https://clinicaltrials.gov/study/NCT06316232*