Clinical trial NCT04783493: Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Official title: Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gait Disorders, Neurologic
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial
Primary purpose: TREATMENT

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 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.

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 patients who have gait and balance changes refractory to dopaminergic therapy.

Eligibility criteria: Inclusion Criteria:

1. Men and women (not pregnant) aged between 21 and 80 years old;
2. 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).
3. Mini-examination of mental status greater than or equal to 24 points;
4. Able to give informed consent in accordance with institutional policies;
5. Able to meet all testing and monitoring requirements, as defined by the study protocol;

Exclusion Criteria:

1. Patients with unstabilized psychiatric comorbidities
2. Impossibility to consent to your participation in the study.
3. Patients with uncontrolled infection or other pre-existing uncontrolled medical conditions (eg, decompensated diabetes, high blood pressure, pneumo or symptomatic heart disease).
4. Concomitant treatment with other experimental drugs.
5. Pregnant or breastfeeding women.
6. Presence of chronic pain in the lower limbs.
7. 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).

Primary outcomes:
measure: TUG
timeFrame: Post-stimulation: immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Secondary outcomes:
measure: Secondary outcomes will be the change on other gait measures, gait speed.
timeFrame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
measure: Secondary outcomes will be the effects of stimulation on other gait measures, step length, stride length and step width.
timeFrame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
measure: Secondary outcomes will be the effects of stimulation on other gait measures, cadencia.
timeFrame: Baseline, immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
measure: Secondary outcomes will be the effects of stimulation on balance after noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.
timeFrame: Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
measure: Determination of possible adverse effects of noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.
timeFrame: Immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
measure: Assess the effects of transcutaneous magnetic stimulation of the dorsal cord on quality of life in patients with parkinson's disease
timeFrame: Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
measure: To evaluate the effects of noninvasive stimulation of the dorsal cord in the presence of freezing gait, through the application of questionnaires.
timeFrame: Baseline, immediately after the fifth day of stimulation, seven, fourteen, twenty-one and twenty-eight days after finishing the stimulation.
measure: Assess the effects of transcutaneous magnetic stimulation of the spinal cord on the other motor symptoms of Parkinson's disease.
timeFrame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
measure: Assess the effects of transcutaneous magnetic stimulation of the spinal cord on cognition of Parkinson's disease.
timeFrame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Rubens G Cury, MD
role: STUDY_DIRECTOR
References: