Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease (NCT04783493) | Clinical Trial Compass
UnknownNot Applicable
Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Brazil38 participantsStarted 2021-01-01
Plain-language 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 issues directly impacts patients' quality of life. Experimental epidural spinal cord stimulation studies have suggested positive effects on locomotion among PD patients, but the effects of non invasive stimulation have never been explored.
Who can participate
Age range21 Years – 81 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
TUG
Timeframe: Post-stimulation: immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
✕. 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).