Magnetic stimulation to improve walking in Parkinson's patients with deep brain stimulation

Effects of Magnetic Stimulation of the Dorsal Spinal Cord on Gait in Patients With Parkinson´s Disease and Deep Brain Stimulation

This study is testing if magnetic stimulation can help improve walking and balance in people with Parkinson's disease who have already had deep brain stimulation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Locations: 1 site (Sao Paulo)
• Trial ID: NCT05008289 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of magnetic transcutaneous spinal cord stimulation on gait disorders in patients with Parkinson's disease who have undergone deep brain stimulation. It aims to address the challenges faced by these patients when traditional therapies do not adequately improve their walking and balance. Participants will receive magnetic stimulation to potentially enhance their motor function, particularly focusing on gait improvement. The study will include individuals aged 21 to 80 with specific eligibility criteria related to their Parkinson's symptoms and treatment history.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 21 to 80 with Parkinson's disease and deep brain stimulation, experiencing gait and balance issues.

Not a fit: Patients with unstable psychiatric conditions or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve walking and balance in patients with Parkinson's disease who struggle with these symptoms despite existing therapies.

How similar studies have performed: While the use of spinal cord stimulation has been explored, the specific application of magnetic transcutaneous stimulation in this context is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Men and women (non-pregnant) aged between 21 and 80 years;
2. Presence of deep brain stimulation in the subthalamic nucleus or globus pallidus
3. Participants with idiopathic Parkinson's disease at Hoehn Yahr stages between 2 and 4 during off-medication, whose primary symptom includes altered gait and/or balance (score equal to or greater than 1 on sub-item 2.12 of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) \["gait and balance"\]). Patients should present the above symptoms even though they are optimized from a drug point of view and with optimized programming. The criteria to be optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case.
4. Able to give informed consent in accordance with institutional policies;
5. Able to meet all testing and follow-up requirements as defined by the study protocol

Exclusion Criteria:

1. Patients with unstabilized psychiatric comorbidities;
2. Impossibility to consent to their participation in the study;
3. Patients with uncontrolled infection or other uncontrolled pre-existing medical conditions (eg, decompensated diabetes, high blood pressure, symptomatic pneumo or heart disease);
4. Concurrent treatment with other experimental drugs;
5. Pregnant or breastfeeding women;
6. Patients who cannot walk, not even with unilateral aid of a walking aid device or another person, when they are without their medication for Parkinson's Disease (off-medication);
7. Presence of cardiac pacemaker.

Where this trial is running

Sao Paulo

• University of Sao Paulo — Sao Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Rubens G Cury, PhD

Conditions Parkinson Disease; parkinson disease; magnetic transcutaneous stimulation; spinal cord stimulation; gait in parkinson disease; deep brain stimulation