Gait Disorders, NeurologicTMSNCT04783493
Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
A study testing Non-invasive magnetic stimulation of the spinal cord and Coil will not be connected to the stimulation device in people with Gait Disorders, Neurologic, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 81 years
- Conditions the study is for
- Gait Disorders, Neurologic
- What is being tested?
- Non-invasive magnetic stimulation of the spinal cord and Coil will not be connected to the stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
São Paulo, São Paulo, 05403-000
Rubens G Cury, MD, 551126610000, rubens_cury@usp.br
Janaina R Menezes, MD
About this study
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.
Read the 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.
- Conditions
- Gait Disorders, Neurologic
- Being tested
- Non-invasive magnetic stimulation of the spinal cord, Coil will not be connected to the stimulation device
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive magnetic stimulation of the spinal cordDevice
Also called TMS
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
Coil will not be connected to the stimulation deviceOther
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
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE | Active comparator | 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. Receives: Device: Non-invasive magnetic stimulation of the spinal cord |
| PLACEBO | Placebo comparator | 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). Receives: Other: Coil will not be connected to the stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-stimulation: immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Secondary outcomes (9)
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.
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
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.
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
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.
Measured: Baseline, immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
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).
Measured: Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
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.
Measured: Immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
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.
Measured: Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
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.
Measured: Baseline, immediately after the fifth day of stimulation, seven, fourteen, twenty-one and twenty-eight days after finishing the stimulation.
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.
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
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).
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jan 2021
- Primary completion29 Sep 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rubens G Cury, MD, Study director, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783493
- Sponsor's protocol ID
- USaoPaulo
- Acronym
- TMS
- Status last verified
- Mar 2021
- First submitted
- 22 Feb 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: WE CURRENTLY PLACE STUDY DATA ON THE REDCAP PLATFORM
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04783493
- Acronym / sponsor ID
- TMS / USaoPaulo
- Conditions
- Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 29 Sep 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial
| Arm | Type | Receives |
|---|---|---|
| ACTIVE | Active comparator | Device: Non-invasive magnetic stimulation of the spinal cordIn 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. |
| PLACEBO | Placebo comparator | Other: Coil will not be connected to the stimulation deviceIn 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). |
Who may qualify
- Ages
- 21 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive magnetic stimulation of the spinal cordAlso: TMSNon-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 | Device | ACTIVE |
| Coil will not be connected to the stimulation devicecoil 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 | Other | PLACEBO |
Primary outcome
TUG
Time frame: Post-stimulation: immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
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.
9 secondary outcomes
Secondary outcomes will be the change on other gait measures, gait speed.
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Secondary outcomes will be the effects of stimulation on other gait measures, step length, stride length and step width.
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Secondary outcomes will be the effects of stimulation on other gait measures, cadencia.
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
Secondary outcomes will be the effects of stimulation on balance after noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.
Time frame: Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
Determination of possible adverse effects of noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.
Time frame: Immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
Assess the effects of transcutaneous magnetic stimulation of the dorsal cord on quality of life in patients with parkinson's disease
Time frame: Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.
To evaluate the effects of noninvasive stimulation of the dorsal cord in the presence of freezing gait, through the application of questionnaires.
Time frame: Baseline, immediately after the fifth day of stimulation, seven, fourteen, twenty-one and twenty-eight days after finishing the stimulation.
Assess the effects of transcutaneous magnetic stimulation of the spinal cord on the other motor symptoms of Parkinson's disease.
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Assess the effects of transcutaneous magnetic stimulation of the spinal cord on cognition of Parkinson's disease.
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: No. WE CURRENTLY PLACE STUDY DATA ON THE REDCAP PLATFORM
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubens G Cury, MD study director
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive magnetic stimulation of the spinal cord and Coil will not be connected to the stimulation device in people with Gait Disorders, Neurologic, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubens G Cury, MD (5511-26617877, rubens_cury@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TUG (time frame: Post-stimulation: immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.