Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorSamsung Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with Parkinson's disease, diagnosed by the United Kingdom (UK) Parkinson's Disease Society Brain Bank Diagnostic Criteria,

Modified Hoehn and Yahr (H&Y) scale, stage 2~4,

patients who can walk on flat surfaces without the need for a gait aid,

aged ≥50 years old,

Disqualifiers

those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy,

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

those with coexisting neurological conditions, such as spinal cord injury or Stroke,

those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Frequency, ipsilateral M1

    Device

    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

    Device

    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

    Device

    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

    Device

    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.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Ipsilateral High-FrequencyExperimental treatment 1 intervention
Group B: Bilateral High-Frequency1Active comparator 1 intervention
Group C: DLPFC High-FrequencyExperimental treatment 1 intervention
Group D: Bilateral High-Frequency2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Differences of Timed Up and Go Test (TUG)

Measurement for gait function.

Time frame
From baseline T0 to Post-intervention T2 (4 weeks)

Secondary outcomes

1

Differences of Timed Up and Go Test (TUG)

Measurement for gait function.

Time frame
From baseline T0 to During-intervention T1 (2 weeks)
2

Differences of Timed Up and Go Test (TUG)

Measurement for gait function.

Time frame
From baseline T0 to Follow-up T3 (2 months)
3

Differences of Timed Up and Go Test-Cognitive (TUG-Cog)

Measurement for gait and cognitive function.

Time frame
From baseline T0 to During-intervention T1 (2 weeks)
4

Differences of Timed Up and Go Test-Cognitive (TUG-Cog)

Measurement for gait and cognitive function.

Time frame
From baseline T0 to Post-intervention T2 (4 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

National Research Foundation of Korea

Collaborator

Ministry of Food and Drug Safety, Korea

Collaborator

Seoul National University Hospital

Collaborator

Bucheon St. Mary's Hospital

Collaborator

Saint Vincent's Hospital, Korea

Collaborator

Severance Hospital

Collaborator

Kumoh National Institute of Technology

Collaborator

NEUROPHET

Collaborator