The Effects of Noninvasive Brain Stimulation on Physical and Mental Functioning in Older Adults

NCT02436915 | Completed Results DMC

• 1 other identifier: 15-002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine whether augmentation of prefrontal brain excitability using noninvasive transcranial direct current stimulation (tDCS) lessens the severity of the symptom triad associated with cerebral microvascular disease (CMD); that is, slow gait, cognitive dysfunction and depressive symptoms. Investigators will complete this objective by conducting a pilot, double-blinded randomized controlled trial of a 10-day intervention of real versus sham tDCS in 40 subjects.

Conditions

Aging

Keywords

Slow gait; Executive function; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (4)

• Percent Change From Baseline to Post Intervention on Mobility

  Mobility and turning will be assessed by the timed up-and-go test (TUG) (Podsiadlo \& Richardson, 1991). The participant will be seated in an armed chair. On the word "go," the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible. Time to complete the TUG test will be used as the outcome measure.

  baseline, immediately after intervention and 2 weeks post intervention

• Percent Change From Baseline to Post Intervention on Global Cognition Impairment

  The Montreal Cognitive Assessment (MoCA) score is used as the outcome measure of Global Cognition Impairment. MoCA score ranges from 0 to 30. Lower MoCA score represents poorer cognitive function (i.e., more severe Global Cognition Impairment).

  Baseline, immediately after intervention and 2 weeks post intervention

• Percent Change From Baseline to Post Intervention on Dual Task Cost to Walking Speed in 24-meter Walking Test

  Six 24-meter walking trials at a preferred speed are completed and each three of them are in normal or dual task condition. The GaitRite pressure mat (Havertown, PA) will be used to record bilateral foot placements and measure the walking speed. Dual task cost to walking speed is defined as the percent change of walking speed from normal walking to dual task walking. The outcome was calculated by averaging the dual task costs of the six trials.

  baseline, immediately after intervention and 2 weeks post intervention

• Percent Change From Baseline to Post Intervention on Dual Task Cost to Standing Postural Sway Speed

  Postural sway speed - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 30-second trials of standing with eyes open (single task) or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). Dual task cost is defined as the percent change of sway speed from single task standing to dual task standing. The outcome was obtained by averaging the dual task costs of the six trials.

  baseline, immediately after intervention and 2 weeks post intervention

Secondary Outcomes (4)

• Percent Change From Baseline to Post Intervention on Geriatric Depression Scale (GDS) Score

  baseline, immediately after intervention and 2 weeks post intervention

• Percent Change From Baseline to Post Intervention on Trial Making Test (TMT)

  baseline, immediately after intervention and 2 weeks post intervention

• Percent Change From Baseline to Post Intervention on Dual-task Cost to Standing Sway Area

  baseline, immediately after intervention and 2 weeks post intervention

• Percent Change From Baseline to Post Intervention on Dual Task Cost to Stride Time in 24-meter Walking Test

  baseline, immediately after intervention and 2 weeks post intervention

Study Arms (2)

Real tDCS

EXPERIMENTAL

The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) targeting left prefrontal cortex at a target current intensity of 1.5 mA.

Other: Real tDCS

Sham tDCS

SHAM COMPARATOR

The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation with same montage as the "real tDCS", except current will only be applied for the first 60 seconds of each session.

Other: Sham tDCS

Interventions

Real tDCS OTHER

Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.

Real tDCS

Sham tDCS OTHER

For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.

Sham tDCS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Slow gait, defined by an over-ground preferred walking speed of less than or equal to 1.0 m/s.
• Executive dysfunction, defined by a Trail Making Test B z-score of greater than one standard deviation below age- and gender-based norms.

You may not qualify if:

• Non-ambulatory
• Clinical history or brain imaging evidence of a previous stroke
• Parkinson's Disease
• Normal pressure hydrocephalus
• Other neurodegenerative condition
• Severe depression
• Lower-extremity arthritis or pain causing slow gait
• Inability or unwillingness to understand or participate in the study protocol
• Contraindications to MRI or tDCS, including (but not limited to) personal or family history of epilepsy, use of neuro-active drugs, claustrophobia or risk of metal objects in the body.

Sponsors & Collaborators

• Hebrew SeniorLife: lead
• Beth Israel Deaconess Medical Center: collaborator
• The Falk Medical Research Trust, Bank of America, N.A. Trustee: collaborator

Study Sites (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

Results Point of Contact

• Title: Brad Manor
• Organization: Institute for Aging Research, Hebrew SeniorLife

bradmanor@hsl.harvard.edu

617-971-5332

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: May 7, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 5, 2019
• Results First Posted: June 5, 2019

Record last verified: 2018-01

Locations

US (1)