Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients
Recruiting · NCT06350617 · Interventional (participants receive a specific treatment) · Lead sponsor: Samsung Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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,
- patients willing to sign the informed consent.
Exclusion criteria
- 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,
- those with severe on-off phenomena or severe dyskinesia, deemed by the investigators to render participation in the study inappropriate.
- those having contraindications to conduct an MRI study,
- those who are pregnant or lactating,
- patients who have refused to participate in this study.
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, South Korea