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

NCT ID: NCT03191812

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-26
• Study Completion Date: 2021-05-26

Brief Summary

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.

Detailed Description

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: SHAM_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

Interventions

transcranial Direct Current Stimulation (tDCS)

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hebrew SeniorLife

OTHER

Sponsor Role: lead

Responsible Party

Brad Manor

Associate Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brad Manor

Role: PRINCIPAL_INVESTIGATOR

Institute for Aging Research, Hebrew SeniorLife

Locations

Hebrew Rehabilitation Center

Roslindale, Massachusetts, United States

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

United States; Israel

Other Identifiers

2016-26

Identifier Type: -

Identifier Source: org_study_id