뇌졸중 후 무관심을 위한 가속화된 rTMS

실험적: 반복적인 경두개 자기 자극

모든 참가자는 내측 전전두엽 피질(mPFC)에서 가속화된 고용량 반복 경두개 자기 자극(rTMS)을 600회 펄스로 하루 12회, 3일 동안(연속 또는 비연속) 7일 이내에 받게 됩니다. -일 기간.

장치: MagVenture MagPro 경두개 자기 자극(TMS) 시스템

치료는 7일 기간 동안 3일 동안 각각 12번의 약 3분 세션으로 구성됩니다. 참가자 준수 및 유지를 촉진하기 위해 치료일이 연속적일 필요는 없습니다. 단일 세션은 120% rMT(휴지 모터 임계값)의 강도로 dmPFC에 전달되는 600개의 펄스로 구성됩니다. 50Hz 3상 버스트가 2초 동안 전달된 후 8초간 기차 간 간격이 이어집니다. 훈련은 세션당 총 190초 동안 10초마다 총 10회 반복됩니다. 12개의 각 세션 사이에 최소 15분의 세션 간격이 사용됩니다. 따라서 각 치료일은 약 3-4시간 지속됩니다.

다른 이름들:

• Brainsight Neuronavigation 시스템

Change in Apathy Symptoms, as Measured by the Lille Apathy Rating Scale (LARS) Compared to Baseline

The Lille Apathy Rating Scale (LARS) is a validated 33-item structured interview assessing apathy across 9 domains, including intellectual curiosity, emotion, action initiation, self-awareness, productivity, interests, novelty seeking, motivation, and social engagement.

Total scores range from -36 to +36, with higher scores indicating greater severity of apathy (worse outcome) and lower (more negative) scores indicating less apathy (better outcome).

The total score is calculated by summing responses across all items and domains to generate a composite score.

Treatment-Emergent Adverse Events and Side Effects as Assessed by Intermittent Theta Burst Stimulation Review of Systems (iTBS ROS)

A review of systems questionnaire (Intermittent Theta Burst Stimulation Review of Systems; iTBS ROS) was administered repeatedly during each treatment day to assess treatment-emergent symptoms.

Symptoms were rated on a scale from 0 to 5 (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, 5 = severe), with higher scores indicating greater symptom severity (worse outcome).

Values reported represent the average symptom severity across all assessments collected during the 3 treatment days for each participant, and then averaged across participants.

Change in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) Compared to Baseline

The Montreal Cognitive Assessment (MoCA) is a clinical assessment of cognitive function. The MoCA assesses multiple cognitive domains including memory, visuospatial skills, executive function, attention, concentration, calculation, language, abstraction, and orientation. The MoCA can be administered in approximately 10 minutes and total scores range from 0 to 30 with lower scores correlating with greater degree of cognitive impairment.

Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery Compared to Baseline

Fluid cognition was measured using the iPad-administered NIH Toolbox Cognition Battery (NIHTB-CB). Fluid Cognition Composite scores were calculated by averaging the demographically adjusted (age, education, sex, race/ethnicity; Casaletto et al., 2015) T-scores for 5 NIHTB-CB tests: the flanker inhibitory control, list sorting working memory, pattern comparison processing speed, dimensional change card sort tests, and picture sequence memory. T-Scores have a mean of 50 and a standard deviation of 10. Lower scores indicate worse performance. There are no established thresholds or cutoffs for clinically distinct or diagnostic categories.

Participant Retention Rate

Percentage of participants who completed the study relative to all participants who initiated treatment

Change in Apathy Symptoms, as Measured by the Apathy Evaluation Scale (AES) Compared to Baseline

The Apathy Evaluation Scale (AES) clinically validated rating scale assessing symptoms of apathy. The AES is comprised of 18 items rated on a four-point Likert-Scale assessing and quantifying emotional, behavioral and cognitive aspects of apathy. Total scores on the AES range from 18 to 72 with high scores correlating with greater severity of apathy.

Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form

The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form is a validated patient-reported outcome measure assessing depressive symptoms, including negative mood, cognitive symptoms, and decreased positive affect.

Scores are reported as T-scores standardized to the U.S. general population, where a T-score of 50 represents the population mean and 10 represents the standard deviation.

Higher T-scores indicate greater depressive symptom severity (worse outcome), while lower T-scores indicate fewer depressive symptoms (better outcome).

T-scores of approximately 60 or greater are generally considered indicative of at least mild clinically elevated depressive symptoms, with higher thresholds reflecting increasing severity.