The Short-term Effects of Noninvasive Electrical Brain Stimulation on Dual Tasking in Older Adults
2022년 3월 14일 업데이트: Brad Manor, Hebrew SeniorLife
Optimization of Transcranial Direct Current Stimulation (tDCS) for Dual Task Performance in Older Adults With and Without a History of Falls
The tDCS & Dual Tasking study will compare the effects of transcranial Direct Current Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation) on dual task standing and walking in older adults with and without a recent history of recurrent falls.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The ability to stand and walk safely, especially while performing additional cognitive tasks like talking, reading or decision making, is critical to the preservation of functional independence into old age.
Such "dual tasking" often impairs balance, even in healthy older adults and those with greater dual task "costs" are more likely to suffer future falls.
Transcranial direct current stimulation (tDCS) is a safe, noninvasive and inexpensive means of modulating activity across cortical networks.
A single, 20-minute session of tDCS facilitates brain activity for up to 24 hours.
Through Dr. Manor's previous research in healthy older adults, he has discovered that just 20 minutes of tDCS targeting the left dorsolateral prefrontal cortex (dlPFC)-a region involved in both cognitive and motor function-immediately reduces the dual task costs to balance when standing and walking, and improves performance in the timed up-and-go (TUG) test of mobility.
However, there are several brain networks with known involvement in balance control and dual tasking, and the optimal brain region to target to improve dual task capacity has not been established.
The proposed study will be a double-blinded, sham-controlled study in which older adults both with and without a history of falling undergo dual task assessments immediately before and after single, 20-minute sessions of tDCS designed to target several different brain regions with known involvement in dual tasking and the maintenance of balance.
연구 유형
연구 유형
중재적
등록 (실제)
등록
61
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
"Faller" group
- Aged 65 years and older
- Able to read, write and communicate in English
- Self-report of 2 or more falls within the past 6 months
"Non-Faller" Group
- Aged 65 years and older
- Able to read, write, and communicate in English
- Self-report of 1 or no (zero) falls within the past 6 months
Exclusion Criteria:
- Self-reported diagnosis of Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, history of stroke or other neurodegenerative disorder.
- Self-reported active cancer for which chemo-/radiation therapy is being received.
- Hospitalization within the past 3 months due to acute illness or as a result of a musculoskeletal injury significantly affecting gait and balance.
- Montreal Cognitive Assessment score <18, or insufficient understanding of study procedures following review of the Informed Consent Form. Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- Inability to stand or ambulate unassisted for at least 25 feet.
- Contraindications to tDCS, including a reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, skull, or head, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant), or the presence of any active dermatological condition, such as eczema, on the scalp (see appendix for standardized tDCS screening questionnaire).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
팔의 수
4
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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가짜 비교기: Sham Stimulation
The Sham stimulation intervention will consist of one, twenty-minute session of transcranial direct current stimulation (tDCS) that does not target a cortical area but instead, provides just enough current to create tingling sensations across the scalp to mimic the feeling of receiving the real stimulation.
The sham stimulation will use the same number and placement of electrodes as the real stimulation but with a much smaller total current intensity of 0.5 milliamps (mA).
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
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실험적: M1 Stimulation
The M1 stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex at a total current intensity of 1.5 mA.
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
|
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실험적: DLPFC Stimulation
The DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex at a total current intensity of 1.5 mA.
|
There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
|
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실험적: M1+DLPFC Stimulation
The M1+DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex and the dorsolateral prefrontal cortex simultaneously at a total current intensity of 3.0 mA.
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dual task cost to standing postural sway speed
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to standing postural sway speed will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task.
The dual task cost will be calculated as the percent change in sway speed from single- to dual-task conditions.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Dual task cost to gait speed when walking
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to gait speed when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task.
The dual task cost will be calculated as the percent change in gait speed from single- to dual-task conditions.
|
This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dual task cost to postural sway area
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
The dual task cost to standing postural sway area will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task.
The dual task cost will be calculated as the percent change in postural sway area from single- to dual-task conditions.
|
This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
|
Dual task cost to gait variability when walking
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
The dual task cost to gait variability when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task.
Gait variability will be defined as the coefficient of variation about the average stride time (stride times defined by the time between consecutive heel strides of the same leg).
The dual task cost will be calculated as the percent change in gait variability from single- to dual-task conditions.
|
This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
|
Single task postural sway speed
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
Single task postural sway speed will be calculated from trials of standing without simultaneous performance of a serial subtraction cognitive task.
|
This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
|
Single task postural sway area
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
Single task postural sway area will be calculated from trials of standing without simultaneous performance of a serial subtraction cognitive task.
|
This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
|
Single task gait speed variability when walking
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
Single task gait variability when walking will be calculated from trials of walking without simultaneous performance of a serial subtraction cognitive task.
Gait variability will be defined as the coefficient of variation about the average stride time (stride times defined by the time between consecutive heel strides of the same leg).
|
This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
|
Single task gait speed when walking
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
Single task gait speed when walking will be calculated from trials of walking without simultaneous performance of a serial subtraction cognitive task.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
|
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Mobility
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Mobility will be assessed using the Timed Up-and-Go test in which the amount of time it takes for the participant to stand up from a chair, walk three meters, turn around a cone, walk back, and sit down is recorded.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Executive function
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Executive function will be assessed using the Stroop test.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Cognitive processing speed
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Cognitive processing speed will be assessed using the Symbol Digit Modalities Test (SDMT).
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Attention
기간: This outcome will be assessed immediately before and after each 20-minute session of tDCS
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Attention will be assessed using the Visual Search and Attention Test (VSAT).
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This outcome will be assessed immediately before and after each 20-minute session of tDCS
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Brad Manor, Institute for Aging Research, Hebrew SeniorLife
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)
연구 시작
2017년 5월 26일
기본 완료 (실제)
기본 완료
2019년 11월 26일
연구 완료 (실제)
연구 완료
2021년 5월 26일
연구 등록 날짜
최초 제출
최초 제출
2017년 6월 15일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2017년 6월 15일
처음 게시됨 (실제)
처음 게시됨
2017년 6월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2022년 3월 15일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2022년 3월 14일
마지막으로 확인됨
마지막으로 확인됨
2022년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2016-26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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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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