Status:
UNKNOWN
Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Gait Disorders, Neurologic
Eligibility:
All Genders
21-81 years
Phase:
NA
Brief Summary
Dopaminergic drugs partially alleviate gait problems in Parkinson's disease, but the effects are not sustained in the long-term. Particularly, the freezing of gait, balance problems and other gait iss...
Detailed Description
The present study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial that will assess the efficacy and safety of transcutaneous magnetic spinal cord stimulation in PD...
Eligibility Criteria
Inclusion
- Men and women (not pregnant) aged between 21 and 80 years old;
- Participants with idiopathic Parkinson's disease in Hoehn Yahr stages between 2 and 4 (moderate disease) during off-medication, whose primary symptom includes change in gait and / or balance (score equal to or greater than 1 in subitem 2.12 of the MSD scale -UPDRS \["gait and balance"\]). The participant must also present freezing (block) of gait (score equal to or greater than 1 in sub-item 2.13 of the MSD-UPDRS scale - "freezing"). Patients should experience the above symptoms even though they are optimized from the medication point of view. The criteria for being optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case. The presence of freezing will be confirmed through a specific scale (FOG score).
- Mini-examination of mental status greater than or equal to 24 points;
- Able to give informed consent in accordance with institutional policies;
- Able to meet all testing and monitoring requirements, as defined by the study protocol;
Exclusion
- Patients with unstabilized psychiatric comorbidities
- Impossibility to consent to your participation in the study.
- Patients with uncontrolled infection or other pre-existing uncontrolled medical conditions (eg, decompensated diabetes, high blood pressure, pneumo or symptomatic heart disease).
- Concomitant treatment with other experimental drugs.
- Pregnant or breastfeeding women.
- Presence of chronic pain in the lower limbs.
- Patients who are unable to walk without assistance (cane, crutch, walker) or help from another person when they are without their medications for Parkinson's disease (off-medication).
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04783493
Start Date
January 1 2021
End Date
January 31 2022
Last Update
April 2 2021
Active Locations (1)
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1
University of São Paulo
São Paulo, São Paulo, Brazil, 05403-000