Back to resultsTranscutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease (TMS)
Primary Purpose
Gait Disorders, Neurologic
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Non-invasive magnetic stimulation of the spinal cord
Coil will not be connected to the stimulation device
Sponsored by
About this trial
This is an interventional treatment trial for Gait Disorders, Neurologic
Eligibility Criteria
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.
- 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).
Sites / Locations
- University of São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ACTIVE
PLACEBO
Arm Description
In the active group, non-invasive transcutaneous magnetic stimulation of the dorsal spine will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (chest level T2-T3). The stimulation intensity will represent 100% of the motor threshold, this determined by abdominal muscle contractions, found from single pulses, applied gradually every 10 seconds until the contractions appear. The intermittent theta burst stimulation protocol will consist of 20 stimulation trains, with an interval of 8 seconds between trains, each train will have 20 bursts, and each burst will have 3 pulses at 50 Hz repeated at 5 Hz. In total, 1200 pulses will be applied for 3 minutes and 58 seconds.
In the placebo group, a coil will be allocated in the T2-T3 thoracic region, however this coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, far from its field of view, to provide idea from the sound stimulus that is being stimulated. To create a sensation of muscle contraction and impression of active stimulation, both the placebo and active groups will be subjected to the sensory effect of transcutaneous electrical neurostimulation (TENS).
Outcomes
Primary Outcome Measures
TUG
The primary outcome will be the change in gait speed between pre-stimulation and post-stimulation conditions between the two groups (active and placebo) assessed using the 5-meter total Timed Up and Go Test (TUG). Mixel model ANOVA, with TUG as the dependent variable, and time and group as independent variables -'group' would have two levels ('active' and 'placebo'). Our alternative hypothesis is that 'the time vs. group' interaction effect is significant. Then we should use post hoc statistical tests to explore our data further and to compare the effects of active versus placebo at different time levels.
Secondary Outcome Measures
Secondary outcomes will be the change on other gait measures, gait speed.
Evaluate the gait speed through measurements obtained through sensors for gait, during the gait of five meters.
Secondary outcomes will be the effects of stimulation on other gait measures, step length, stride length and step width.
Evaluate step length, stride length and step width through measurements obtained through sensors for gait, during the gait of five meters.
Secondary outcomes will be the effects of stimulation on other gait measures, cadencia.
Evaluate the cadencia through measurements obtained through sensors for gait, during the gait of five meters.
Secondary outcomes will be the effects of stimulation on balance after noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.
Evaluate the improvement of the balance through the application of questionnaires,which will be the Activities-specific Balance Confidence Scale (ABC) and Falls Efficacy Scale (FES I).
Determination of possible adverse effects of noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.
The patient will be actively questioned about the appearance of adverse effects of noninvasive stimulation of the dorsal cord.
Assess the effects of transcutaneous magnetic stimulation of the dorsal cord on quality of life in patients with parkinson's disease
The questionnaire Parkinson Disease Questionnaire-39 (PDQ-39) will be applied.
To evaluate the effects of noninvasive stimulation of the dorsal cord in the presence of freezing gait, through the application of questionnaires.
The questionnaires New Freezing of Gait Questionnaire (NFOG-Q), Sub-items 2.12 and 2.13 MDS-UPDRS will be applied.
Assess the effects of transcutaneous magnetic stimulation of the spinal cord on the other motor symptoms of Parkinson's disease.
Other motor effects will be assessed by applying the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) item III and FOG SCORE.
Assess the effects of transcutaneous magnetic stimulation of the spinal cord on cognition of Parkinson's disease.
Possible changes in cognition will be assessed based on the application of the Frontal assessment battery (FAB).
Full Information
NCT ID
NCT04783493
First Posted
February 22, 2021
Last Updated
March 30, 2021
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04783493
Brief Title
Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Acronym
TMS
Official Title
Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 29, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorders, Neurologic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial
Masking
ParticipantInvestigator
Masking Description
The random sequence will be generated by a computer program (randomization.com) using randomly exchanged blocks (size of four per block, active ratio / placebo 1: 1). Randomization will be stratified according to the severity of symptoms (TUG> 33 seconds = severe group; TUG ≤ 33 seconds = light group). The researchers will be specifically instructed not to break the randomization schedule in any way. Different researchers will carry out randomization, clinical evaluation and stimulation. Patients will be blinded to randomization.
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACTIVE
Arm Type
Active Comparator
Arm Description
In the active group, non-invasive transcutaneous magnetic stimulation of the dorsal spine will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (chest level T2-T3). The stimulation intensity will represent 100% of the motor threshold, this determined by abdominal muscle contractions, found from single pulses, applied gradually every 10 seconds until the contractions appear. The intermittent theta burst stimulation protocol will consist of 20 stimulation trains, with an interval of 8 seconds between trains, each train will have 20 bursts, and each burst will have 3 pulses at 50 Hz repeated at 5 Hz. In total, 1200 pulses will be applied for 3 minutes and 58 seconds.
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
In the placebo group, a coil will be allocated in the T2-T3 thoracic region, however this coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, far from its field of view, to provide idea from the sound stimulus that is being stimulated. To create a sensation of muscle contraction and impression of active stimulation, both the placebo and active groups will be subjected to the sensory effect of transcutaneous electrical neurostimulation (TENS).
Intervention Type
Device
Intervention Name(s)
Non-invasive magnetic stimulation of the spinal cord
Other Intervention Name(s)
TMS
Intervention Description
Non-invasive transcutaneous magnetic stimulation of the dorsal spine will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (chest level T2-T3). The stimulation intensity will represent 100% of the motor threshold. The intermittent theta burst stimulation protocol will consist of 20 stimulation trains, with an interval of 8 seconds between trains, each train will have 20 bursts, and each burst will have 3 pulses at 50 Hz repeated at 5 Hz. In total, 1200 pulses will be applied for 3 minutes and 58 seconds
Intervention Type
Other
Intervention Name(s)
Coil will not be connected to the stimulation device
Intervention Description
coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, far from its field of view, to provide idea from the sound stimulus that is being stimulated
Primary Outcome Measure Information:
Title
TUG
Description
The primary outcome will be the change in gait speed between pre-stimulation and post-stimulation conditions between the two groups (active and placebo) assessed using the 5-meter total Timed Up and Go Test (TUG). Mixel model ANOVA, with TUG as the dependent variable, and time and group as independent variables -'group' would have two levels ('active' and 'placebo'). Our alternative hypothesis is that 'the time vs. group' interaction effect is significant. Then we should use post hoc statistical tests to explore our data further and to compare the effects of active versus placebo at different time levels.
Time Frame
Post-stimulation: immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Secondary Outcome Measure Information:
Title
Secondary outcomes will be the change on other gait measures, gait speed.
Description
Evaluate the gait speed through measurements obtained through sensors for gait, during the gait of five meters.
Time Frame
Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Title
Secondary outcomes will be the effects of stimulation on other gait measures, step length, stride length and step width.
Description
Evaluate step length, stride length and step width through measurements obtained through sensors for gait, during the gait of five meters.
Time Frame
Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Title
Secondary outcomes will be the effects of stimulation on other gait measures, cadencia.
Description
Evaluate the cadencia through measurements obtained through sensors for gait, during the gait of five meters.
Time Frame
Baseline, immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
Title
Secondary outcomes will be the effects of stimulation on balance after noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.
Description
Evaluate the improvement of the balance through the application of questionnaires,which will be the Activities-specific Balance Confidence Scale (ABC) and Falls Efficacy Scale (FES I).
Time Frame
Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
Title
Determination of possible adverse effects of noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.
Description
The patient will be actively questioned about the appearance of adverse effects of noninvasive stimulation of the dorsal cord.
Time Frame
Immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
Title
Assess the effects of transcutaneous magnetic stimulation of the dorsal cord on quality of life in patients with parkinson's disease
Description
The questionnaire Parkinson Disease Questionnaire-39 (PDQ-39) will be applied.
Time Frame
Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
Title
To evaluate the effects of noninvasive stimulation of the dorsal cord in the presence of freezing gait, through the application of questionnaires.
Description
The questionnaires New Freezing of Gait Questionnaire (NFOG-Q), Sub-items 2.12 and 2.13 MDS-UPDRS will be applied.
Time Frame
Baseline, immediately after the fifth day of stimulation, seven, fourteen, twenty-one and twenty-eight days after finishing the stimulation.
Title
Assess the effects of transcutaneous magnetic stimulation of the spinal cord on the other motor symptoms of Parkinson's disease.
Description
Other motor effects will be assessed by applying the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) item III and FOG SCORE.
Time Frame
Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Title
Assess the effects of transcutaneous magnetic stimulation of the spinal cord on cognition of Parkinson's disease.
Description
Possible changes in cognition will be assessed based on the application of the Frontal assessment battery (FAB).
Time Frame
Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubens G Cury, MD
Phone
5511-26617877
Email
rubens_cury@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens G Cury, MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubens G Cury, MD
Phone
551126610000
Email
rubens_cury@usp.br
First Name & Middle Initial & Last Name & Degree
Janaina R Menezes, MD
First Name & Middle Initial & Last Name & Degree
Glaucia A Nunes, PT
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
WE CURRENTLY PLACE STUDY DATA ON THE REDCAP PLATFORM
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Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
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