Using brain stimulation with treadmill training to improve walking in Parkinson's patients
Effects of Repetitive Trans Spinal Magnetic Stimulation Associated With Treadmill Gait Training on Gait Disorders in Patients With Parkinson's Disease
This study is testing whether using brain stimulation along with treadmill training can help people with Parkinson's walk faster and improve their overall movement and balance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, SP) |
| Trial ID | NCT05938673 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of repetitive transspinal magnetic stimulation (rTSMS) combined with treadmill gait training on improving rapid gait speed in patients with Parkinson's Disease. The researchers hypothesize that this combined approach will be more effective than treadmill training alone in alleviating gait symptoms. The study will also assess various clinical and neurophysiological measures, including balance, mobility, and quality of life. Additionally, potential side effects of the intervention will be monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with moderate Parkinson's Disease who experience gait disturbances and can walk independently or with a unilateral assistive device.
Not a fit: Patients with unstable psychiatric conditions or other neurological disorders that affect walking may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking ability and overall quality of life for patients with Parkinson's Disease.
How similar studies have performed: While the use of non-invasive brain stimulation for gait improvement is gaining interest, this specific combination of rTSMS and treadmill training is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women over the age of 18; * Participants with PD at Hoehn Yahr stages between 2 and 4 (moderate disease) while on-medication (i.e., at the time when their usual dopaminergic medication is clinically effective), whose primary symptom includes gait disturbance (score equal to or greater than 1 in subitem 2.12 of the MSD-UPDRS scale). Patients will be evaluated for the presence of freezing gait (freezing) through the Freezing of Gait Score (FOG-SCORE). * While on on-medication, be able to walk independently for 30 meters or with a unilateral assistive device. * Mini Mental State Examination (MMSE) score greater than or equal to 23. * Sign the informed consent form. Exclusion Criteria: * Patients with unstabilized psychiatric comorbidities; * Individuals who have other neurological disorders, musculoskeletal, orthopedic, cardiovascular and respiratory disorders that may affect the ability to walk on the treadmill will be excluded. * Individuals with labyrinthine problems, using medication that may interfere with balance and performance in tests and treadmill training will be excluded. * Individuals who have undergone deep brain stimulation surgery or epidural spinal cord stimulation will be excluded. * Patients with uncontrolled infection or other uncontrolled pre-existing medical conditions (eg uncontrolled diabetes, high blood pressure, symptomatic lung or heart disease); * Concomitant treatment with other experimental drugs; * Pregnant or breastfeeding women. * Presence of chronic low back and lower limb pain. * Patients who cannot walk without assistance (cane, crutch, walker) or help from another person. * Patients with metal implants and a cardiac pacemaker. * Patient with a history of neurosurgery.
Where this trial is running
São Paulo, SP
- Hospital das Clínicas da Faculdade de Medicina da USP — São Paulo, Sp, Brazil (Recruiting)
Study contacts
- Principal investigator: Rubens G Cury, MD PHD — Hospital das Clínicas da Faculdade de Medicina da USP
- Study coordinator: Rubens G Cury, MD PHD
- Email: rubens_cury@usp.br
- Phone: +55 11 26617877
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.