The Short-term Effects of Noninvasive Electrical Brain Stimulation on Dual Tasking in Older Adults
2022年3月14日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
61
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年歳以上 (高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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偽コンパレータ：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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実験的：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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実験的：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.
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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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実験的：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dual task cost to standing postural sway speed
時間枠：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
時間枠：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.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dual task cost to postural sway area
時間枠：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.
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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 variability when walking
時間枠：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 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.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway speed
時間枠：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway speed will be calculated from trials of standing 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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Single task postural sway area
時間枠：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway area will be calculated from trials of standing 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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Single task gait speed variability when walking
時間枠：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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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).
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task gait speed when walking
時間枠：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Brad Manor、Institute for Aging Research, Hebrew SeniorLife
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年5月26日
一次修了 (実際)
2019年11月26日
研究の完了 (実際)
2021年5月26日
試験登録日
最初に提出
2017年6月15日
QC基準を満たした最初の提出物
2017年6月15日
最初の投稿 (実際)
2017年6月19日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月15日
QC基準を満たした最後の更新が送信されました
2022年3月14日
最終確認日
2022年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
transcranial Direct Current Stimulation (tDCS)の臨床試験
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完了