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Completed

NCT Number: NCT03191812

The Short-term Effects of Noninvasive Electrical Brain Stimulation on Dual Tasking in Older Adults

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Other

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.

Primary outcomes

  1. Dual task cost to standing postural sway speed

    Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.

    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.

  2. Dual task cost to gait speed when walking

    Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.

    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.

Secondary outcomes

  1. Dual task cost to postural sway area

    Time frame: 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.

  2. Dual task cost to gait variability when walking

    Time frame: 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.

  3. Single task postural sway speed

    Time frame: 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.

  4. Single task postural sway area

    Time frame: 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.

  5. Single task gait speed variability when walking

    Time frame: 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).

  6. Single task gait speed when walking

    Time frame: 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.

  7. Mobility

    Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.

    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.

  8. Executive function

    Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.

    Executive function will be assessed using the Stroop test.

  9. Cognitive processing speed

    Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.

    Cognitive processing speed will be assessed using the Symbol Digit Modalities Test (SDMT).

  10. Attention

    Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS

    Attention will be assessed using the Visual Search and Attention Test (VSAT).

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Registry information

Official study title

Optimization of Transcranial Direct Current Stimulation (tDCS) for Dual Task Performance in Older Adults With and Without a History of Falls

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Jun 19, 2017
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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