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파킨슨병 무감동증에 대한 가속화된 TMS

2026년 11월 2일 업데이트: Medical University of South Carolina

파킨슨병 무관심증에 대한 가속화된 경두개 자기 자극(TMS)

This single-site, open-label pilot study will evaluate the feasibility, tolerability, and preliminary efficacy of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD). Fifteen participants with PD and clinically significant apathy will undergo imaging (EEG and MRI) and one day of TMS including twelve iTBS sessions across two visits. Outcomes include adherence, tolerability, changes in apathy (Lille Apathy Rating Scale), functional engagement, and neural target engagement assessed via resting-state fMRI and EEG. Follow-up assessments will occur at one week, two weeks, and four weeks post-treatment. Fifteen participants with PD without clinically significant apathy will act as a comparison group and will undergo imaging (EEG and MRI), assessments, and questionnaires at baseline. Caregivers for each participant will complete questionnaires regarding their co-participant's symptoms as well as answer questions about their experience as a caregiver.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This study is designed to explore a new treatment option for people with Parkinson's disease who experience apathy, which means loss of motivation or interest in daily activities. Apathy is common in Parkinson's disease and can lower quality of life, but current treatments are limited. Investigators are testing whether a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) is tolerable, acceptable and can be used to improve apathy in patients with Parkinson's disease. TMS delivers brief magnetic pulses to specific areas of the brain that are linked to motivation and decision-making. In this study, Investigators will use an "accelerated" version of TMS, which gives several short sessions in a single day, reducing the number of visits required. The purpose of this research is to see whether this treatment approach is feasible, tolerable and and potentially effective at treating apathy in people with Parkinson's disease. If successful, this research study will hopefully lead to a larger study in the future where the efficacy of the treatments can be studied.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • 모병
        • Medical University of South Carolina
        • 수석 연구원:
          • Daniel Lench, PhD
        • 연락하다:
          • Emily Laramie Study Coordinator
          • 전화번호: 843-792-3873
          • 이메일: laramie@musc.edu

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

45년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

PD Apathy Participant

Inclusion criteria:

  1. 45-85 years of age
  2. Diagnosis of PD based on UK Brain Bank diagnostic criteria
  3. Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37
  4. Stable on Parkinsons medications (not expected to change through the course of the treatment)
  5. Ability to have a co-participant/caregiver who meets criteria below.

Exclusion Criteria:

  1. Claustrophobia or inability to lie supine in the scanner for an extended period of time
  2. barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
  3. Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, and non-removable hair clips or piercings.
  4. Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder.
  5. Pregnancy
  6. Individuals with a history of seizure(s).
  7. Presence of cognitive impairment or dementia that would impact participant's capacity to give informed consent or ability to participate in study procedures as indicated by chart review and/or measured by the MoCA (<21)
  8. Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year

Co-participant/Caregiver

Inclusion Criteria:

  1. 18 years of age or older
  2. Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's apathy and everyday functioning.

Exclusion criteria:

1) Unable to engage with study procedures in which co-participant input is needed.

PD Control Group

Inclusion Criteria:

  1. Age matched to participants in the PD Apathy group (45 to 85 years of age)
  2. Diagnosis of PD based on UK Brain Bank diagnostic criteria [17]
  3. Stable on Parkinsons medications (not expected to change through the course of the study)

Exclusion Criteria:

  1. Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37
  2. Claustrophobia or inability to lie supine in the scanner for an extended period of time
  3. Contraindications to MRI safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, and non-removable hair clips or piercings
  4. Neuropsychiatric disorder diagnosis
  5. Uncorrected visual or hearing impairments, as indicated by self-report
  6. Pregnancy
  7. Presence of cognitive impairment or dementia that would impact participant's capacity to give informed consent or ability to participate in study procedures as indicated by chart review and/or measured by the MoCA (<21)

Co-participant/Caregiver

Inclusion Criteria:

3) 18 years of age or older 4) Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's mood and everyday functioning.

Exclusion criteria:

2) Unable to engage with study procedures in which co-participant input is needed.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: PD Apathetic group

Participants with Parkinson's disease and clinically significant apathy receive accelerated iTBS rTMS targeting the left dorsomedial prefrontal cortex (dmPFC) using a MagVenture MagPro system with a cooled figure-of-eight coil and Brainsight neuronavigation (slightly off midline). Resting motor threshold (rMT) is determined on the first stimulation visit (PEST) and stimulation is delivered at 120% rMT. Treatment occurs on one day, with 12 sessions separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; ~190 s), totaling 7,200 pulses overall. Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) is assessed before/after sessions.
장치: Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC)

Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC) (MagVenture MagPro with cooled figure-of-eight coil; Brainsight neuronavigation; 120% rMT; 1 treatment day; 12 sessions; 600 pulses/session; 10-15 min inter-session interval).
간섭 없음: Non-Apathetic PD Control Group

Participants with Parkinson's Disease without clinically significant apathy will not undergo TMS but will act as a comparison group at baseline. This group will undergo imaging (EEG and MRI), assessments, and answer questionnaires with their caregiver.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
TMS adherence
기간: Day 1 through Day 14 (6 treatment days over approximately 2 weeks)

Proportion of planned accelerated iTBS sessions completed. Adherence is calculated as number of iTBS sessions completed out of 48 scheduled sessions (6 treatment days × 8 sessions/day).
Day 1 through Day 14 (6 treatment days over approximately 2 weeks)
Frequency and Severity of TMS-Induced Side effects (TMS tolerability and acceptability)
기간: Measured during each treatment day (6 days within a 2-week period)

Participant-reported tolerability/acceptability assessed with a standardized questionnaire capturing frequency and severity of common TMS side effects (e.g., headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety), collected during treatment days (pre/post sessions).
Measured during each treatment day (6 days within a 2-week period)
Apathy severity as measured by the Lille Apathy Rating Scale
기간: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment

Change in apathy measured by the Lille Apathy Rating Scale (LARS) patient and caregiver/informant versions; analyzed as change from baseline to post-treatment and follow-up timepoints. Possible scores range from -36 to 36 with higher scores indicating greater apathy.
Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment
Target engagement (dmPFC network modulation)
기간: Baseline MRI/EEG assessments (Days 0-1) and post-treatment MRI/EEG assessments (Days 14-15)

Change in dmPFC target engagement measured by (1) resting-state fMRI functional connectivity of dmPFC to motivation/effort-related nodes and (2) EEG waveform/response metrics during motivation/effort tasks, comparing pre- vs post-intervention.
Baseline MRI/EEG assessments (Days 0-1) and post-treatment MRI/EEG assessments (Days 14-15)

2차 결과 측정

결과 측정
측정값 설명
기간
Goal attainment
기간: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment

Change in goal-directed behavior measured by Bangor Goal-Setting Interview outcomes, including proportion/percent attainment of individualized goals across assessment timepoints.
Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment
Change in apathy as measured by the Dimensional Apathy Scale
기간: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"

Change in apathy-related symptoms measured using the Dimensional Apathy Scale (DAS), including patient/informant reports where applicable. Scores range from 0-24 on each of the three subscales (executive, emotional, and behavior/ cognitive initiation) with higher scores indicating greater apathy.
Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"
Change in apathy-related behavior as measured by the Frontal Systems Behavior Scale
기간: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"

Change in apathy-related symptoms measured using the Frontal Systems Behavior Scale (FRSBE), including patient/informant reports where applicable. Apathy components include 14 questions scored 0-4 for a range of scores 0-56 with higher scores indicating greater apathy.
Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Medical University of South Carolina

수사관

  • 수석 연구원: Daniel Lench, Medical University of South Carolina

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 9월 9일

기본 완료 (추정된)

2027년 9월 9일

연구 완료 (추정된)

2027년 9월 9일

연구 등록 날짜

최초 제출

2026년 1월 7일

QC 기준을 충족하는 최초 제출

2026년 2월 2일

처음 게시됨 (실제)

2026년 2월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Pro00147039

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다