Effects of rTSMS Associated With Treadmill Training in Patients With Parkinson's Disease
NCT ID: NCT05938673
Last Updated: 2025-08-27
Study Results
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Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2022-10-01
2024-05-01
Brief Summary
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The combination of non-invasive neuromodulation with other therapies can enhance the effectiveness of rehabilitation, increasing plasticity and clinical efficacy, offering a greater and more sustained effect than either therapy alone.It's recommended that patients with PD perform a specific exercise for walking, such as treadmill training (tt), that imposes an external rhythm and concentration of attention on gait, acting as an external cue or marker, promoting a more stable gait, reducing gait variability and decreasing risk of falls.
It is proposed, in this study, to develop a new treatment model through the integration of two promising and complementary approaches to improve gait disorders in PD: rTSMS and tt.
Thus, the investigators idealized the realization of the first randomized, double-blind, placebo-controlled, parallel, phase III clinical trial that will evaluate the efficacy of tt associated with rTSMS in patients with PD.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sham repetitive transpinal magnetic stimulation
In the Sham group a coil will be positioned in the T2-T3 thoracic region disconnected to the stimulation device and the active coil will be positioned about 15 cm behind the patient, away from his field of vision, to provide sound stimulus.
Sham stimulation
During sham stimulation, a circular magnetic coil will be positioned in the T2-T3 toracic region disconnected to the stimulation device and the active coil will be positioned about 15 cm behind the patient, away from his field of vision, to provide sound stimulus. To create a sensation of muscle contraction and impression of active stimulation, the group will be submitted to the sensory effect of transcutaneous electrical neurostimulation (TENS) for 5 minutes, with surface electrodes placed in parallel at the T2-T3, with the parameters (80Hz,150ms, 60 mA).Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity.
Active repetitive transpinal magnetic stimulation
In the Active group, the patient will receive intermittent theta burst stimulation (iTBS) in the T2-T3 region while seated using a circular magnetic coil positioned at 90º, handle facing to the right, connected to a magnetic stimulator.
Active stimulation- intermittent theta-burst (iTBS) stimulation
During active stimulation, patients will receive intermittent theta-burst (iTBS) stimulation in T2-T3 toracic region while seated using a circular magnetic coil positioned at 90º, handle facing to the right, connected to a magnetic stimulator.Each participant will receive a total of 1,200 rTsMS pulses at 120% of resting motor threshold, determined by abdominal muscle contractions. In 3 minutes and 58 seconds, 20 trains with 20 bursts and each burst with 3 pulses at 50 Hz repeated at 5Hz with an intertrain interval of 8 seconds will be applied.Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity.
Interventions
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Active stimulation- intermittent theta-burst (iTBS) stimulation
During active stimulation, patients will receive intermittent theta-burst (iTBS) stimulation in T2-T3 toracic region while seated using a circular magnetic coil positioned at 90º, handle facing to the right, connected to a magnetic stimulator.Each participant will receive a total of 1,200 rTsMS pulses at 120% of resting motor threshold, determined by abdominal muscle contractions. In 3 minutes and 58 seconds, 20 trains with 20 bursts and each burst with 3 pulses at 50 Hz repeated at 5Hz with an intertrain interval of 8 seconds will be applied.Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity.
Sham stimulation
During sham stimulation, a circular magnetic coil will be positioned in the T2-T3 toracic region disconnected to the stimulation device and the active coil will be positioned about 15 cm behind the patient, away from his field of vision, to provide sound stimulus. To create a sensation of muscle contraction and impression of active stimulation, the group will be submitted to the sensory effect of transcutaneous electrical neurostimulation (TENS) for 5 minutes, with surface electrodes placed in parallel at the T2-T3, with the parameters (80Hz,150ms, 60 mA).Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity.
Eligibility Criteria
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Inclusion Criteria
* Participants with PD at Hoehn Yahr stages between 2 and 4 (moderate disease) while on-medication (i.e., at the time when their usual dopaminergic medication is clinically effective), whose primary symptom includes gait disturbance (score equal to or greater than 1 in subitem 2.12 of the MSD-UPDRS scale). Patients will be evaluated for the presence of freezing gait (freezing) through the Freezing of Gait Score (FOG-SCORE).
* While on on-medication, be able to walk independently for 30 meters or with a unilateral assistive device.
* Mini Mental State Examination (MMSE) score greater than or equal to 23.
* Sign the informed consent form.
Exclusion Criteria
* Individuals who have other neurological disorders, musculoskeletal, orthopedic, cardiovascular and respiratory disorders that may affect the ability to walk on the treadmill will be excluded.
* Individuals with labyrinthine problems, using medication that may interfere with balance and performance in tests and treadmill training will be excluded.
* Individuals who have undergone deep brain stimulation surgery or epidural spinal cord stimulation will be excluded.
* Patients with uncontrolled infection or other uncontrolled pre-existing medical conditions (eg uncontrolled diabetes, high blood pressure, symptomatic lung or heart disease);
* Concomitant treatment with other experimental drugs;
* Pregnant or breastfeeding women.
* Presence of chronic low back and lower limb pain.
* Patients who cannot walk without assistance (cane, crutch, walker) or help from another person.
* Patients with metal implants and a cardiac pacemaker.
* Patient with a history of neurosurgery.
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Rubens G Cury, MD PHD
Role: PRINCIPAL_INVESTIGATOR
Hospital das Clínicas da Faculdade de Medicina da USP
Locations
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Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Countries
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References
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Arii Y, Sawada Y, Kawamura K, Miyake S, Taichi Y, Izumi Y, Kuroda Y, Inui T, Kaji R, Mitsui T. Immediate effect of spinal magnetic stimulation on camptocormia in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1221-6. doi: 10.1136/jnnp-2014-307651. Epub 2014 Apr 29.
Chung CL, Mak MK, Hallett M. Transcranial Magnetic Stimulation Promotes Gait Training in Parkinson Disease. Ann Neurol. 2020 Nov;88(5):933-945. doi: 10.1002/ana.25881. Epub 2020 Sep 8.
de Andrade EM, Ghilardi MG, Cury RG, Barbosa ER, Fuentes R, Teixeira MJ, Fonoff ET. Spinal cord stimulation for Parkinson's disease: a systematic review. Neurosurg Rev. 2016 Jan;39(1):27-35; discussion 35. doi: 10.1007/s10143-015-0651-1. Epub 2015 Jul 30.
Fuentes R, Petersson P, Siesser WB, Caron MG, Nicolelis MA. Spinal cord stimulation restores locomotion in animal models of Parkinson's disease. Science. 2009 Mar 20;323(5921):1578-82. doi: 10.1126/science.1164901.
Reis Menezes J, Bernhart Carra R, Aline Nunes G, da Silva Simoes J, Jacobsen Teixeira M, Paiva Duarte K, Ciampi de Andrade D, Barbosa ER, Antonio Marcolin M, Cury RG. Transcutaneous magnetic spinal cord stimulation for freezing of gait in Parkinson's disease. J Clin Neurosci. 2020 Nov;81:306-309. doi: 10.1016/j.jocn.2020.10.001. Epub 2020 Oct 20.
Takakusaki K. Neurophysiology of gait: from the spinal cord to the frontal lobe. Mov Disord. 2013 Sep 15;28(11):1483-91. doi: 10.1002/mds.25669.
Yadav AP, Nicolelis MAL. Electrical stimulation of the dorsal columns of the spinal cord for Parkinson's disease. Mov Disord. 2017 Jun;32(6):820-832. doi: 10.1002/mds.27033. Epub 2017 May 12.
Yang YR, Tseng CY, Chiou SY, Liao KK, Cheng SJ, Lai KL, Wang RY. Combination of rTMS and treadmill training modulates corticomotor inhibition and improves walking in Parkinson disease: a randomized trial. Neurorehabil Neural Repair. 2013 Jan;27(1):79-86. doi: 10.1177/1545968312451915. Epub 2012 Jul 10.
Agari T, Date I. Spinal cord stimulation for the treatment of abnormal posture and gait disorder in patients with Parkinson's disease. Neurol Med Chir (Tokyo). 2012;52(7):470-4. doi: 10.2176/nmc.52.470.
Fenelon G, Goujon C, Gurruchaga JM, Cesaro P, Jarraya B, Palfi S, Lefaucheur JP. Spinal cord stimulation for chronic pain improved motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2012 Feb;18(2):213-4. doi: 10.1016/j.parkreldis.2011.07.015. Epub 2011 Aug 23. No abstract available.
Santana MB, Halje P, Simplicio H, Richter U, Freire MAM, Petersson P, Fuentes R, Nicolelis MAL. Spinal cord stimulation alleviates motor deficits in a primate model of Parkinson disease. Neuron. 2014 Nov 19;84(4):716-722. doi: 10.1016/j.neuron.2014.08.061. Epub 2014 Oct 30.
Pinto de Souza C, Hamani C, Oliveira Souza C, Lopez Contreras WO, Dos Santos Ghilardi MG, Cury RG, Reis Barbosa E, Jacobsen Teixeira M, Talamoni Fonoff E. Spinal cord stimulation improves gait in patients with Parkinson's disease previously treated with deep brain stimulation. Mov Disord. 2017 Feb;32(2):278-282. doi: 10.1002/mds.26850. Epub 2016 Nov 10.
Samotus O, Parrent A, Jog M. Spinal Cord Stimulation Therapy for Gait Dysfunction in Advanced Parkinson's Disease Patients. Mov Disord. 2018 May;33(5):783-792. doi: 10.1002/mds.27299. Epub 2018 Feb 14.
de Lima-Pardini AC, Coelho DB, Souza CP, Souza CO, Ghilardi MGDS, Garcia T, Voos M, Milosevic M, Hamani C, Teixeira LA, Fonoff ET. Effects of spinal cord stimulation on postural control in Parkinson's disease patients with freezing of gait. Elife. 2018 Aug 2;7:e37727. doi: 10.7554/eLife.37727.
Mitsui T, Arii Y, Taniguchi K, Tsutsumi S, Takahara M, Mabuchi M, Sumitomo N, Matsuura M, Kuroda Y. Efficacy of Repetitive Trans-spinal Magnetic Stimulation for Patients with Parkinson's Disease: a Randomised Controlled Trial. Neurotherapeutics. 2022 Jul;19(4):1273-1282. doi: 10.1007/s13311-022-01213-y. Epub 2022 Jun 27.
Other Identifiers
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57119022.4.1001.0068
Identifier Type: -
Identifier Source: org_study_id
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