Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06350617
Other study ID # 2023-12-028
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2024
Est. completion date September 30, 2025

Study information

Verified date April 2024
Source Samsung Medical Center
Contact Won Hyuk Chang, PhD
Phone +82-2-3410-6068
Email wh.chang@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.


Description:

rTMS treatment for patients with Parkinson's disease is traditionally based on stimulating the neural network of brain. The widely-used traditional rTMS treatment protocol involves high-frequency stimulation over the bilateral primary motor cortex (M1) to enhance motor and gait functions. However, concerns have arisen regarding the effect of rTMS on motor recovery in patients with Parkinson's disease. Although still subject to debate, a possible reason for the diverse results of rTMS applied is the uniform application protocol to individuals with varying pathologies and functional reserves, aimed at enhancing recovery. Therefore, this study was aimed to determine the effects of protocols of rTMS therapy based on the functional reserve of each patient with Parkinson's disease. Based on screening evaluations (Timed Up and Go Test (TUG), Timed Up and Go Dual Task-Cognitive (TUG-Cog)), investigators hypothesized that patients could be categorized into two groups: 1) priority in motor functional reserve, 2) priority in cognitive functional reserve. For each group, investigators plan to randomly assign patients to experimental and control groups to demonstrate the efficacy of different rTMS protocols based on functional reserves compared to conventional high-frequency rTMS applied to the bilateral M1.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: 1. patients with Parkinson's disease, diagnosed by the United Kingdom (UK) Parkinson's Disease Society Brain Bank Diagnostic Criteria, 2. Modified Hoehn and Yahr (H&Y) scale, stage 2~4, 3. patients who can walk on flat surfaces without the need for a gait aid, 4. aged =50 years old, 5. patients willing to sign the informed consent. Exclusion Criteria: 1. those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy, 2. those with cognitive impairment, confirmed through the Montreal Cognitive Assessment (MoCA) test as follows: < 7 points: Illiterate < 13 points: Education duration 0.5-3 years < 16 points: Education duration 4-6 years < 19 points: Education duration 7-9 years < 20 points: Education duration 10 years or more 3. those with coexisting neurological conditions, such as spinal cord injury or Stroke, 4. those with major psychiatric disorders, such as major depression, schizophrenia, or dementia, 5. those with severe on-off phenomena or severe dyskinesia, deemed by the investigators to render participation in the study inappropriate. 6. those having contraindications to conduct an MRI study, 7. those who are pregnant or lactating, 8. patients who have refused to participate in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
High-Frequency, ipsilateral M1
rTMS intervention: 20 sessions of 10-Hz rTMS at 90% resting motor threshold (RMT), 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: ipsilateral primary motor cortex of lower extremity. Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions. Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.
High-Frequency, bilateral M1
rTMS intervention: 20 sessions of 10-Hz rTMS at 90% resting motor threshold (RMT), 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: bilateral primary motor cortex of lower extremity. Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions. Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.
High-Frequency, Lt. DLPFC
rTMS intervention: 20 sessions of 10-Hz rTMS at 90% resting motor threshold (RMT), 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: Lt. DLPFC Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions. Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.
High-Frequency, bilateral M1
rTMS intervention: 20 sessions of 10-Hz rTMS at 90% resting motor threshold (RMT), 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: bilateral primary motor cortex of lower extremity. Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions. Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (9)

Lead Sponsor Collaborator
Samsung Medical Center Bucheon St. Mary's Hospital, Kumoh National Institute of Technology, Ministry of Food and Drug Safety, Korea, National Research Foundation of Korea, NEUROPHET, Saint Vincent's Hospital, Korea, Seoul National University Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences of Timed Up and Go Test (TUG) Measurement for gait function. From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Timed Up and Go Test (TUG) Measurement for gait function. From baseline T0 to During-intervention T1 (2 weeks)
Secondary Differences of Timed Up and Go Test (TUG) Measurement for gait function. From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Timed Up and Go Test-Cognitive (TUG-Cog) Measurement for gait and cognitive function. From baseline T0 to During-intervention T1 (2 weeks)
Secondary Differences of Timed Up and Go Test-Cognitive (TUG-Cog) Measurement for gait and cognitive function. From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Timed Up and Go Test-Cognitive (TUG-Cog) Measurement for gait and cognitive function. From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III Measurement for motor function of patients with Parkinson's disease. Score ranges from 0 to 132; higher score indicates more severity of disease status From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of MDS-UPDRS, Part III Measurement for motor function of patients with Parkinson's disease. Score ranges from 0 to 132; higher score indicates more severity of disease status From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of New Freezing of Gait Questionnaire (FoG-Q) Measurement for gait function of patients with Parkinson's disease Score ranges from 0 to 28; higher score indicates more severity of disease status From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of New Freezing of Gait Questionnaire (FoG-Q) Measurement for gait function of patients with Parkinson's disease Score ranges from 0 to 28; higher score indicates more severity of disease status From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Digit span Test Measurement for cognitive function From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Digit span Test Measurement for cognitive function From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Trail making Test Measurement for cognitive function From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Trail making Test Measurement for cognitive function From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Gait lab parameter (Gait speed) Measurement for gait function. Gait speed (km/hr) will be measured From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Gait lab parameter (Gait speed) Measurement for gait function. unit: km/hr Gait speed (km/hr) will be measured From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Gait lab parameter (Stride length) Measurement for gait function Stride length (m) will be measured From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Gait lab parameter (Stride length) Measurement for gait function Stride length (m) will be measured From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Gait lab parameter (Step count) Measurement for gait function Step count will be measured From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Gait lab parameter (Step count) Measurement for gait function Step count will be measured From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Gait lab parameter (Cadence) Measurement for gait function Cadence (step count/min) will be measured From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Gait lab parameter (Cadence) Measurement for gait function Cadence (step count/min) will be measured From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Gait lab parameter (Swing ratio) Measurement for gait function Swing ratio (% of swing phase of 1 gait cycle) will be measured From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Gait lab parameter (Swing ratio) Measurement for gait function Swing ratio (% of swing phase of 1 gait cycle) will be measured From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Gait lab parameter (Stride time) Measurement for gait function Stride time (unit- second, time from heel strike to next heel strike) will be measured From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Gait lab parameter (Stride time) Measurement for gait function Stride time (unit- second, time from heel strike to next heel strike) will be measured From baseline T0 to Follow-up T3 (2 months)
Secondary Differences of Gait lab parameter (Pressure distribution) Measurement for gait function Pressure distribution (unit - pecentage, pressure distribution among heel, mild, and toe) will be measured From baseline T0 to Post-intervention T2 (4 weeks)
Secondary Differences of Gait lab parameter (Pressure distribution) Measurement for gait function Pressure distribution (unit - pecentage, pressure distribution among heel, mild, and toe) will be measured From baseline T0 to Follow-up T3 (2 months)
See also
  Status Clinical Trial Phase
Completed NCT06037590 - A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops™ Relative to INBRIJA® Phase 1
Enrolling by invitation NCT04799418 - STEM-PD Open Label Extension (OLE) N/A
Not yet recruiting NCT06074393 - Caregiving in Advanced PD: A Tailored Support Group N/A
Completed NCT05699161 - Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson Phase 1/Phase 2
Not yet recruiting NCT05599659 - The Calgary Movement Disorders Advanced Care Pilot Program N/A
Completed NCT04140708 - Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease N/A
Recruiting NCT03924414 - Trial of Parkinson's And Zoledronic Acid Phase 4
Recruiting NCT06203106 - NYSCF Scientific Discovery Biobank
Not yet recruiting NCT06400017 - Mechanism and Application of DBS in the Treatment of PD N/A
Recruiting NCT04797611 - STEM-Parkinson's Disease N/A
Not yet recruiting NCT06174948 - The Use of the CUE1 in People With Parkinson's Disease and Related Disorders N/A
Recruiting NCT05934747 - Aim 3 Particle Swarm Optimization PIGD N/A
Enrolling by invitation NCT04701177 - Digitally-enhanced, Decentralized, Multi-omics Observational Cohort
Recruiting NCT05962489 - Sleep-specific DBS Therapy in Parkinson's Disease N/A
Recruiting NCT05931692 - Virtual Reality and Fear of Falling in Parkinson's Disease
Recruiting NCT04468919 - Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation Toolkit N/A
Completed NCT04925622 - Complex Eye Movements in Parkinson's Disease and Related Movement Disorders
Recruiting NCT04214509 - LIPAD - LRRK2 International Parkinson's Disease Study
Active, not recruiting NCT05677633 - Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease Phase 1
Recruiting NCT06247423 - High-frequency Alternating Current Stimulation for Tremor in Parkinson's Disease. N/A