---
title: Improve gait balance and speech
nct_id: NCT05402163
phase: NA
status: RECRUITING
sponsor: University of Toronto
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT05402163"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05402163"
last_fetched: "2026-05-10T14:07:18.416Z"
source: "Parkinson's Pathways (curated)"
---
# Improve gait balance and speech

**Goal (in five words):** Improve gait balance and speech

**Official Title:** Adaptive/Closed Loop vs. Continuous/Open Loop Deep Brain Stimulation of Subthalamic Nucleus: a Two-Phase, Cross-Over, Double-Blind Trial in Patients With Parkinson's Disease

**Trial ID:** [NCT05402163](https://clinicaltrials.gov/study/NCT05402163)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** University of Toronto
- **Target Enrollment:** 10 participants
- **Start Date:** 2024-06-01
- **Completion Date:** 2025-06-01
- **Conditions:** Parkinson Disease
- **Interventions:** Adaptive DBS, Continuous DBS
- **Intervention Types:** DEVICE

## Summary For Families

Goal: find out whether adaptive, closed-loop stimulation of the subthalamic nucleus can reduce disabling gait, balance, or speech problems that sometimes get worse with standard continuous DBS. Approach: the team will replace the IPG with a Medtronic device that reads local field potentials and automatically adjusts stimulation in real time, delivering pulses only when brain signals indicate they are needed, and compare that to steady, continuous stimulation in a blinded, cross-over design. Eligibility: enrolling 10 adults age 18 to 80 who already have bilateral STN Medtronic leads and need an IPG replacement, who have gait, balance, or speech issues that improve when DBS is turned off and who have usable LFP signals on at least one side; people with non-Medtronic systems, major medical or psychiatric problems, or other conditions that could affect outcomes are excluded.

## Eligibility

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

### Full Criteria

```
Inclusion Criteria:

* PD treated with bilateral STN DBS using Medtronic lead
* Able to provide informed consent and comply with study protocol
* Need to replace the implantable pulse generator (IPG) due to battery end of life
* Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient
* Evidence that these disabling gait and/or balance and/or speech issues are worsened by DBS, i.e. they improve after turning DBS off.
* Use of contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other one
* Good LFP signal (assessable only after IPG replacement with Percept) in at least one hemisphere

Exclusion Criteria:

* Previous DBS surgery without Medtronic products
* Potential use of any therapeutic stimulation configuration (such as bipolar) during the study which will prevent the use of aDBS
* Presence of any other disorders potentially impacting the outcome measures (e.g. orthopaedic issues)
* Medically unstable
* Severe non-motor problems, such as depression, dementia, etc.
```

## Locations (1)

- Movement Disorders Centre - Toronto Western Hospital, Toronto, Ontario, Canada _(43.7064, -79.3986)_
  - Alfonso Fasano, MD, PhD — (CONTACT) — (416) 603-5800 — alfonso.fasano@uhn.ca
  - Alexandra Boogers, MBBCh — (CONTACT) — (416) 603-5800 — alexandra.boogers@uhn.ca
  - Alfonso Fasano, MD, PhD — (PRINCIPAL_INVESTIGATOR)

---

*Canonical: https://parkinsonspathways.com/trial/NCT05402163*  
*HTML version: https://parkinsonspathways.com/trial/NCT05402163*  
*Source data: https://clinicaltrials.gov/study/NCT05402163*