파킨슨병의 운동 증상에 대한 시간적 간섭 자극

실험적: 티아이에스 그룹

이 군의 참가자는 2주간의 중재 기간 동안 내측 창백구를 표적으로 하는 능동적 경두개 시간 간섭 자극을 받게 됩니다.

장치: 경두개 시간적 간섭 자극(TIS)

경두개 시간적 간섭 자극(TIS)은 두피 전극을 통해 두 개의 고주파 교류를 전달하여 깊은 뇌 영역에서 저주파 간섭장을 생성하는 비침습적 뇌 자극 기술입니다. 본 연구에서 TIS는 파킨슨병 환자의 신경 활동을 조절하기 위해 내부 창백구(GPi)를 표적으로 합니다. 참가자들은 2주 동안 10회의 자극 세션을 받습니다. 위약 TIS 조건은 동일한 설정을 사용하지만 간섭 패턴을 생성하지 않고 저주파 전류를 적용합니다.

가짜 비교기: Sham Group

Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period, without therapeutic stimulation.

장치: 경두개 시간적 간섭 자극(TIS)

경두개 시간적 간섭 자극(TIS)은 두피 전극을 통해 두 개의 고주파 교류를 전달하여 깊은 뇌 영역에서 저주파 간섭장을 생성하는 비침습적 뇌 자극 기술입니다. 본 연구에서 TIS는 파킨슨병 환자의 신경 활동을 조절하기 위해 내부 창백구(GPi)를 표적으로 합니다. 참가자들은 2주 동안 10회의 자극 세션을 받습니다. 위약 TIS 조건은 동일한 설정을 사용하지만 간섭 패턴을 생성하지 않고 저주파 전류를 적용합니다.

Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score

Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).

Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score

A responder was defined as a participant with a reduction of at least 5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) total score. Scores range from 0 to 132, with higher scores indicating more severe motor impairment; therefore, a reduction in score indicates improvement.

Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score

Change in non-motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) (Non-Motor Experiences of Daily Living). The total score ranges from 0 to 52, with higher scores indicating more severe non-motor symptoms (worse outcome).

Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score

Change in motor symptoms affecting daily living assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) (Motor Experiences of Daily Living). The total score ranges from 0 to 52, with higher scores indicating more severe motor difficulties in daily living (worse outcome).

Change From Baseline in the Epworth Sleepiness Scale Score

Change in daytime sleepiness assessed using the Epworth Sleepiness Scale . The Epworth Sleepiness Scale is a self-administered questionnaire consisting of 8 items, with total scores ranging from 0 to 24, where higher scores indicate greater daytime sleepiness (worse outcome).

Change From Baseline in the Parkinson's Disease Sleep Scale-2 Score

Change in sleep disturbances assessed using the Parkinson's Disease Sleep Scale-2.

The Parkinson's Disease Sleep Scale-2 is a patient-reported questionnaire consisting of 15 items, with total scores ranging from 0 to 60, where higher scores indicate more severe sleep disturbances (worse outcome).

Change From Baseline in the Gait Performance Measures

Changes in gait performance will be assessed using an instrumented gait mat during single-task and dual-task walking conditions.

Spatiotemporal gait parameters, including gait speed, step length, stride length, step width, cadence, and gait variability, will be collected during standardized walking trials.

Improvements in gait performance are indicated by increased gait speed, longer step and stride length, and reduced gait variability under both single-task and dual-task conditions.

Change From Baseline in the Balance Performance Measures

Changes in balance performance will be assessed using a force platform during standardized standing balance tasks.

Center of pressure (COP) parameters, including COP path length, sway area, and sway velocity, will be derived from force platform recordings to quantify postural stability.

Improved balance performance is indicated by reduced COP displacement, smaller sway area, and lower sway velocity.

Change From Baseline in the Magnetic Resonance Imaging (MRI) Measures

Changes in brain structure and/or function will be assessed using magnetic resonance imaging (MRI).

MRI data will be acquired to evaluate intervention-related changes in brain regions associated with motor control. Imaging-derived measures may include structural and functional metrics obtained from standardized MRI protocols.

Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore

Change from baseline in the bradykinesia subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total bradykinesia subscore ranges from 0 to 48, with higher scores indicating more severe bradykinesia.

Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore

Change from baseline in the rigidity subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total rigidity subscore ranges from 0 to 20, with higher scores indicating more severe rigidity.

Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore

Change from baseline in the axial signs subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total axial signs subscore ranges from 0 to 20, with higher scores indicating more severe axial motor impairment.

Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore

Change from baseline in the tremor subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total tremor subscore ranges from 0 to 40, with higher scores indicating more severe tremor.

Change From Baseline in the Home Diary Assessment of Motor States (Medication-ON Without Dyskinesia)

The motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF.

Baseline assessment will be defined as the average percentage of waking time spent in ON states over three consecutive days immediately prior to the intervention. The 1-week assessment will be defined as the average percentage of waking time spent in ON states over the five intervention days of the first intervention week, and the 2-week assessment as the average over the five intervention days of the second intervention week.

The outcome measure is defined as the percentage of total recorded waking time spent in ON states, calculated from the home diary data. A higher percentage of time spent in ON states indicates milder motor symptoms and better motor control.

Change From Baseline in the Home Diary Assessment of Motor States (Medication-OFF)

The motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF.

Baseline assessment will be defined as the average percentage of waking time spent in the Medication-OFF state over three consecutive days immediately prior to the intervention. Week 1 and Week 2 assessments will be calculated as the average percentage of waking time spent in the Medication-OFF state over the five intervention days of each intervention week.

The outcome measure is defined as the percentage of total recorded waking time spent in the Medication-OFF state, calculated from the home diary data. A lower percentage of time spent in the Medication-OFF state indicates milder motor symptoms and better motor control.

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index

Change in quality of life assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39). The PDQ-39 consists of 39 items across 8 domains, with total scores ranging from 0 to 100, where higher scores indicate poorer health-related quality of life (worse outcome).

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score

Change from baseline in the mobility domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer mobility-related quality of life.

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score

Change from baseline in the activities of daily living domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of daily living-related quality of life.

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score

Change from baseline in the emotional well-being domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of emotional well-being-related quality of life.

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score

Change from baseline in the stigma domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of stigma-related quality of life.

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score

Change from baseline in the social support domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of social support-related quality of life.

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score

Change from baseline in the cognitions domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of cognitions-related quality of life.

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score

Change from baseline in the communication domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of communication-related quality of life.

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score

Change from baseline in the bodily discomfort domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of bodily discomfort-related quality of life.