Individualized Neuro-Modulation Paired With Cerebellar Therapy (IMPACT)
연구 개요
상세 설명
Cerebellar damage causes debilitating ataxia affecting balance, coordination, speech, and cognition. Rehabilitation therapy is the main treatment for ataxia because pharmacological therapeutics are extremely limited. Non-invasive brain stimulation has shown promise in improving motor function and has an excellent safety profile. However, optimal stimulation sites and efficacy when combined with rehabilitation remain unclear.
We hypothesize that three weeks of intensive rehabilitation therapy paired with personalized transcranial direct current stimulation (tDCS) will produce greater functional improvements in people with cerebellar damage compared to therapy with sham stimulation.
This double-blind, randomized, sham-controlled trial will enroll participants with cerebellar damage. We will determine stimulation sites using multimodal neuroimaging and electric field modeling and then check their response to stimulation. If they show MRI response to stimulation and it is well-tolerated, they will be eligible to receive 30 hours of training (one hour, twice daily), with active or sham tDCS during one of the daily sessions Primary outcomes are the Scale for Assessment and Rating of Cerebellar Ataxia (SARA) and Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia), assessed pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
This research addresses a critical gap in treatment options for cerebellar ataxia by testing whether personalized neuromodulation enhances rehabilitation outcomes.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Anthony J Gonzalez, BS
- 전화번호: 443-923-2716
- 이메일: gonzalezan@kennedykrieger.org
연구 연락처 백업
- 이름: Derek J Eversley, BS
- 전화번호: 443-923-2716
- 이메일: eversley@kennedykrieger.org
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21205
- 모병
- Motion Analysis Lab in the Kennedy Krieger Institute
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연락하다:
- Anthony J Gonzalez, BS
- 전화번호: 443-923-2716
- 이메일: gonzalezan@kennedykrieger.org
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수석 연구원:
- Amy J Bastian, PhD, PT
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18-75 years
- Males and Females
- Disorders that predominantly affect the cerebellum: damage from stroke, tumor or degeneration (genetic or non-genetic causes, congenital hypoplasia).
Exclusion Criteria:
- Diagnoses or impairments that interfere with task execution or data interpretation.
- Heart pacemaker or other MRI-incompatible implanted metal device
- Metallic foreign body in their eye or head
- Experience with severe claustrophobia
- Experience discomfort from the MRI scan, such as excessive heating of tattoos
- Seizures or history of seizure disorder
- Alcohol or substance use disorder (self-report)
- Diagnosed history of severe psychiatric disorder such as depression, schizophrenia (self-report)
- Metallic foreign body in their eye or head (except the mouth e.g. dental fillings)
- Specific medications: tricyclic anti-depressants or neuroleptic medication
- Any medical condition (including orthopedic, pain, cardiopulmonary or other) that limits safe participation in exercise training
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Active stimulation combined with therapy.
Once a stimulation site is determined, subjects will receive 20 minutes of active tDCS stimulation daily.
Subjects will also receive one hour of therapy, twice daily.
Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility.
Subjects will complete up to 30 therapy sessions.
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Each participant will choose a domain that they would like to focus on.
Choices are: 1) walking and balance control, 2) hand dexterity and arm control, or 3) speech articulation, prosody, and intelligibility.
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가짜 비교기: Sham stimulation combined with therapy.
Once a stimulation site is determined, subjects will receive 20 minutes of sham tDCS stimulation daily.
Subjects will also receive one hour of therapy, twice daily.
Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility.
Subjects will complete up to 30 therapy sessions.
|
Each participant will choose a domain that they would like to focus on.
Choices are: 1) walking and balance control, 2) hand dexterity and arm control, or 3) speech articulation, prosody, and intelligibility.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Scale for the Assessment and Rating of Ataxia (SARA)
기간: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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The SARA is a tool for assessing ataxia.
SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).
The scores are based on patient performance of: gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, heel-shin slide.
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Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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Patient-Reported Outcome Measure of Ataxia
기간: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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The PROM-Ataxia is a self reported questionnaire used by researchers to evaluate the daily impact and progression of cerebellar ataxia directly from the patient's perspective.
The questionnaire encompasses 70 total items within 3 main domains: 1) Physical: Gait, manual dexterity, swallowing (dysphagia), and visual/ocular motor control.
2) Activities of Daily Living (ADL): Managing household chores, employment, driving, and self-care.
3)Mental: Mood, anxiety, motivation, and cognitive tasks (e.g., multitasking and comprehension).
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Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Amy J Bastian, PhD, PT, Motion Analysis Lab in the Kennedy Krieger Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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