Clinical trial NCT06350617: Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients
Official title: Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease and Parkinsonism
Keywords: Parkinson's Disease
rTMS
Functional reserve
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
name: Ministry of Food and Drug Safety, Korea
name: Seoul National University Hospital
name: Bucheon St. Mary's Hospital
name: Saint Vincent's Hospital, Korea
name: Severance Hospital
name: Kumoh National Institute of Technology
name: NEUROPHET
First posted: 2024-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences of Timed Up and Go Test (TUG)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
Secondary outcomes:
measure: Differences of Timed Up and Go Test (TUG)
timeFrame: From baseline T0 to During-intervention T1 (2 weeks)
measure: Differences of Timed Up and Go Test (TUG)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
timeFrame: From baseline T0 to During-intervention T1 (2 weeks)
measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of MDS-UPDRS, Part III
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of New Freezing of Gait Questionnaire (FoG-Q)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of New Freezing of Gait Questionnaire (FoG-Q)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Digit span Test
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Digit span Test
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Trail making Test
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Trail making Test
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Gait lab parameter (Gait speed)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Gait lab parameter (Gait speed)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Gait lab parameter (Stride length)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Gait lab parameter (Stride length)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Gait lab parameter (Step count)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Gait lab parameter (Step count)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Gait lab parameter (Cadence)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Gait lab parameter (Cadence)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Gait lab parameter (Swing ratio)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Gait lab parameter (Swing ratio)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Gait lab parameter (Stride time)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Gait lab parameter (Stride time)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
measure: Differences of Gait lab parameter (Pressure distribution)
timeFrame: From baseline T0 to Post-intervention T2 (4 weeks)
measure: Differences of Gait lab parameter (Pressure distribution)
timeFrame: From baseline T0 to Follow-up T3 (2 months)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Hyuk Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: