Parkinson DiseaseTMSNCT05008289
Effects of Magnetic Stimulation of the Dorsal Spinal Cord on Gait in Patients With Parkinson´s Disease and Deep Brain Stimulation
A study testing Magnetic transcutaneous spinal cord stimulation and Transcutaneous electrical nerve stimulation in people with Parkinson Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Gait disorders are symptoms that significantly compromise the quality of life and functionality of patients with Parkinson's disease (PD). When they are not responsive to drug dopaminergic therapy and deep brain stimulation (DBS), the management of these symptoms is a challenge in clinical practice. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Magnetic transcutaneous spinal cord stimulation and Transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Nov 2020to 1 Jul 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (non-pregnant) aged between 21 and 80 years;
- Presence of deep brain stimulation in the subthalamic nucleus or globus pallidus
- Participants with idiopathic Parkinson's disease at Hoehn Yahr stages between 2 and 4 during off-medication, whose primary symptom includes altered gait and/or balance (score equal to or greater than 1 on sub-item 2.12 of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) ["gait and balance"]). Patients should present the above symptoms even though they are optimized from a drug point of view and with optimized programming. The criteria to be optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case.
- Able to give informed consent in accordance with institutional policies;
- Able to meet all testing and follow-up requirements as defined by the study protocol
Who cannot join
- Patients with unstabilized psychiatric comorbidities;
- Impossibility to consent to their participation in the study;
- Patients with uncontrolled infection or other uncontrolled pre-existing medical conditions (eg, decompensated diabetes, high blood pressure, symptomatic pneumo or heart disease);
- Concurrent treatment with other experimental drugs;
- Pregnant or breastfeeding women;
- Patients who cannot walk, not even with unilateral aid of a walking aid device or another person, when they are without their medication for Parkinson's Disease (off-medication);
- Presence of cardiac pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Gait disorders are symptoms that significantly compromise the quality of life and functionality of patients with Parkinson's disease (PD). When they are not responsive to drug dopaminergic therapy and deep brain stimulation (DBS), the management of these symptoms is a challenge in clinical practice. Although deep brain stimulation is useful in the motor symptoms of Parkinson's disease, gait symptoms remains a challenge in patients undergoing this therapy. This is because, in addition to adjustments in the DBS programming not adding evident benefit in some patients with gait disorders, motor symptoms tend to progress over the years. In this context, spinal cord invasive electrical stimulation was proposed as a potential and effective therapy in a group of patients with PD who presented with gait impairment. More recently, the application of transcutaneous magnetic stimulation of the spinal cord has emerged as a possible therapeutic option, as it could stimulate neural elements in a non-invasive way. The general objective will be to study the effect of transcutaneous magnetic stimulation of the spinal cord on gait in PD patients with deep brain stimulation refractory to dopaminergic therapy. The method of the present study will be a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial that will evaluate the efficacy of transcutaneous magnetic stimulation of the spinal cord in patients with PD and deep brain stimulation who present gait disorders refractory to dopaminergic therapy. 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 Timed Up and Go Test (TUG). Secondary outcomes will be the effects of stimulation on other gait measures (speed, step length, stride length, cadence, step width, sway time, support time and the presence of blocks), other motor symptoms (Unified Parkinson's Disease Rating Scale), cognitive alterations, quality of life and side effects. Statistical analysis will be performed using ANOVA for repeated measures and 38 patients will be included. The expected results are supported by transcutaneous magnetic stimulation of the spinal cord, which may improve gait disorders in participants with PD and DBS.
- Conditions
- Parkinson Disease
- Being tested
- Magnetic transcutaneous spinal cord stimulation, Transcutaneous electrical nerve stimulation
- Keywords
- parkinson disease, magnetic transcutaneous stimulation, spinal cord stimulation, gait in parkinson disease, deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic transcutaneous spinal cord stimulationDevice
Also called TMS
In the active group, non-invasive spinal cord stimulation will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (thoracic level T2-T3). The intensity of stimulation will represent 100% of the motor threshold, which is determined by abdominal muscle contractions, found from single pulses, gradually applied every 10 seconds until the onset of contractions. 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 Hertz repeated at 5 Hertz. In total 1200 pulses will be applied for 3 minutes and 58 seconds.
Transcutaneous electrical nerve stimulationDevice
Also called TENS
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). The surface electrodes of TENS (model Neurodyn®️, Ibramed®️) will be placed in parallel at the height of the thoracic level T2-T3, with the following parameters: 80Hertz, 150ms, approximately at 60 miliampère.
In the placebo group, a coil will be allocated in the thoracic region T2-T3, however this coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, away from its field of view, to provide the idea from the sound stimulus that it is being stimulated.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE | Active comparator | Magnetic transcutaneous spinal cord stimulation Receives: Device: Magnetic transcutaneous spinal cord stimulation; Device: Transcutaneous electrical nerve stimulation |
| PLACEBO | Sham comparator | Not described Receives: Device: Transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go - Test 5 Meters (TUG-Test 5M)
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 hypotesis 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: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation
Secondary outcomes (13)
Freezing of gait score (FOG SCORE)
Change in FOG SCORE between pre-stimulation and post-stimulation conditions.Minimum value 0 and maximum value 36. Higher value is worse.
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Percentage of freezing by video analysis of Timed Up and Go - Test
Change in percentage between pre-stimulation and post-stimulation conditions
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Part III
Change in UPDRS PART III between pre-stimulation and post-stimulation conditions. Minimum value 0 and maximum value 132. Higher value is worse.
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Timed Up and Go - Test 5 Meters (TUG-Test 5M) Dual Task
Change in gait speed between pre-stimulation and post-stimulation conditions
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Mini Balance Evaluation Systems Test (Mini-BESTest)
Change in balance between pre-stimulation and post-stimulation conditions. Minimum value 0 and maximum value 108. Higher value is better.
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
New Freezing of Gait Questionnaire (NFOG-Q)
Change in NFOG-Q between pre-stimulation and post-stimulation conditions. Minimum 0 Maximum 28. Higher value is worse.
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, fourteen days after the stimulation, twenty-one days after the stimulation, twenty-eight, thirty-five and forty-two days after the stimulation.
Subitems 2.12 and 2.13 of Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change between pre-stimulation and post-stimulation conditions
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, fourteen days after the stimulation, twenty-one days after the stimulation, twenty-eight, thirty-five and forty-two days after the stimulation
Parkinson's Disease Questionnaire 39 (PDQ-39);
Change in PDQ-39 between pre-stimulation and post-stimulation conditions. Minimum value 0% and maximum value 100%. Higher value is worse.
Measured: Baseline, seven days after the stimulation, twenty-eight days after stimulation.
Falls Efficacy Scale (FES-I)
Change in FES-I between pre-stimulation and post-stimulation conditions. Minimum value 16 and maximum value 64. Higher value is worse.
Measured: Baseline, seven days after the stimulation, twenty-eight days after stimulation.
Activities-specific Balance Confidence (ABC) Scale
Change in ABC scale between pre-stimulation and post-stimulation conditions. Minimum value 0 and maximum value 100%. Higher value is better.
Measured: Baseline, seven days after the stimulation, twenty-eight days after stimulation.
Visual analog scale (VAS)
Change in pain between pre-stimulation and post-stimulation conditions. Minimum value 0 and maximum value 10. Higher value is worse.
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Patient Global Impression of Change (PGIC)
Impression of change post-stimulation conditions
Measured: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, fourteen days after the stimulation, twenty-one days after the stimulation, twenty-eight, thirty-five and forty-two days after the stimulation
Frontal assessment battery (FAB);
Change in executive function between pre-stimulation and post-stimulation conditions. Minimum value 0 and maximum value 18. Higher value is better.
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 posted17 Aug 2021
- Study start27 Nov 2020
- Primary completion1 May 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008289
- Sponsor's protocol ID
- 16233819800000068
- Acronym
- TMS
- Status last verified
- Jan 2026
- First submitted
- 9 Aug 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnetic Stimulation of the Dorsal Spinal Cord on Gait in Patients With Parkinson´s Disease and Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT05008289
- Acronym / sponsor ID
- TMS / 16233819800000068
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, magnetic transcutaneous stimulation, spinal cord stimulation, gait in parkinson disease, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 17 Aug 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.
Gait disorders are symptoms that significantly compromise the quality of life and functionality of patients with Parkinson's disease (PD). When they are not responsive to drug dopaminergic therapy and deep brain stimulation (DBS), the management of these symptoms is a challenge in clinical practice. Although deep brain stimulation is useful in the motor symptoms of Parkinson's disease, gait symptoms remains a challenge in patients undergoing this therapy. This is because, in addition to adjustments in the DBS programming not adding evident benefit in some patients with gait disorders, motor symptoms tend to progress over the years. In this context, spinal cord invasive electrical stimulation was proposed as a potential and effective therapy in a group of patients with PD who presented with gait impairment. More recently, the application of transcutaneous magnetic stimulation of the spinal cord has emerged as a possible therapeutic option, as it could stimulate neural elements in a non-invasive way. The general objective will be to study the effect of transcutaneous magnetic stimulation of the spinal cord on gait in PD patients with deep brain stimulation refractory to dopaminergic therapy. The method of the present study will be a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial that will evaluate the efficacy of transcutaneous magnetic stimulation of the spinal cord in patients with PD and deep brain stimulation who present gait disorders refractory to dopaminergic therapy. 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 Timed Up and Go Test (TUG). Secondary outcomes will be the effects of stimulation on other gait measures (speed, step length, stride length, cadence, step width, sway time, support time and the presence of blocks), other motor symptoms (Unified Parkinson's Disease Rating Scale), cognitive alterations, quality of life and side effects. Statistical analysis will be performed using ANOVA for repeated measures and 38 patients will be included. The expected results are supported by transcutaneous magnetic stimulation of the spinal cord, which may improve gait disorders in participants with PD and DBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTIVE | Active comparator | Device: Magnetic transcutaneous spinal cord stimulation, Device: Transcutaneous electrical nerve stimulationMagnetic transcutaneous spinal cord stimulation |
| PLACEBO | Sham comparator | Device: Transcutaneous electrical nerve stimulation |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women (non-pregnant) aged between 21 and 80 years;
- Presence of deep brain stimulation in the subthalamic nucleus or globus pallidus
- Participants with idiopathic Parkinson's disease at Hoehn Yahr stages between 2 and 4 during off-medication, whose primary symptom includes altered gait and/or balance (score equal to or greater than 1 on sub-item 2.12 of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) ["gait and balance"]). Patients should present the above symptoms even though they are optimized from a drug point of view and with optimized programming. The criteria to be optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case.
- Able to give informed consent in accordance with institutional policies;
- Able to meet all testing and follow-up requirements as defined by the study protocol
Key exclusion criteria (7 listed)
- Patients with unstabilized psychiatric comorbidities;
- Impossibility to consent to their participation in the study;
- Patients with uncontrolled infection or other uncontrolled pre-existing medical conditions (eg, decompensated diabetes, high blood pressure, symptomatic pneumo or heart disease);
- Concurrent 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 |
|---|---|---|
| Magnetic transcutaneous spinal cord stimulationAlso: TMSIn the active group, non-invasive spinal cord stimulation will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (thoracic level T2-T3). The intensity of stimulation will represent 100% of the motor threshold, which is determined by abdominal muscle contractions, found from single pulses, gradually applied every 10 seconds until the onset of contractions. 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 Hertz repeated at 5 Hertz. In total 1200 pulses will be applied for 3 minutes and 58 seconds. | Device | ACTIVE |
| Transcutaneous electrical nerve stimulationAlso: TENSTo 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). The surface electrodes of TENS (model Neurodyn®️, Ibramed®️) will be placed in parallel at the height of the thoracic level T2-T3, with the following parameters: 80Hertz, 150ms, approximately at 60 miliampère. In the placebo group, a coil will be allocated in the thoracic region T2-T3, however this coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, away from its field of view, to provide the idea from the sound stimulus that it is being stimulated. | Device | ACTIVE, PLACEBO |
Primary outcome
Timed Up and Go - Test 5 Meters (TUG-Test 5M)
Time frame: Baseline, 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 hypotesis 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.
13 secondary outcomes
Freezing of gait score (FOG SCORE)
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Percentage of freezing by video analysis of Timed Up and Go - Test
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Part III
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Timed Up and Go - Test 5 Meters (TUG-Test 5M) Dual Task
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Mini Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
New Freezing of Gait Questionnaire (NFOG-Q)
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, fourteen days after the stimulation, twenty-one days after the stimulation, twenty-eight, thirty-five and forty-two days after the stimulation.
Subitems 2.12 and 2.13 of Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, fourteen days after the stimulation, twenty-one days after the stimulation, twenty-eight, thirty-five and forty-two days after the stimulation
Parkinson's Disease Questionnaire 39 (PDQ-39);
Time frame: Baseline, seven days after the stimulation, twenty-eight days after stimulation.
Falls Efficacy Scale (FES-I)
Time frame: Baseline, seven days after the stimulation, twenty-eight days after stimulation.
Activities-specific Balance Confidence (ABC) Scale
Time frame: Baseline, seven days after the stimulation, twenty-eight days after stimulation.
Visual analog scale (VAS)
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Patient Global Impression of Change (PGIC)
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, fourteen days after the stimulation, twenty-one days after the stimulation, twenty-eight, thirty-five and forty-two days after the stimulation
Frontal assessment battery (FAB);
Time frame: Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic transcutaneous spinal cord stimulation and Transcutaneous electrical nerve stimulation in people with Parkinson Disease, 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: finished, as of the sponsor's last update on 12 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go - Test 5 Meters (TUG-Test 5M) (time frame: Baseline, 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 12 Feb 2026.