N/A
N=19
The Effects of Noninvasive Brain Stimulation on Physical and Mental Functioning in Older Adults
Aging
Bottom Line
View on ClinicalTrials.gov: NCT02436915 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Percent Change From Baseline to Post Intervention on Mobility — -3.0; 10.4; -6.1; 3.4 percent change of TUG time — p=0.24
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Real tDCS (Other); Sham tDCS (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Hebrew SeniorLife
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Post Intervention on Mobility |
-3.0; 10.4; -6.1; 3.4 | 0.24 |
| PRIMARY Percent Change From Baseline to Post Intervention on Global Cognition Impairment |
7.9; 0.1; 12.6; -0.4 | 0.03 sig |
| PRIMARY Percent Change From Baseline to Post Intervention on Dual Task Cost to Walking Speed in 24-meter Walking Test |
14.9; 3.9; 6.1; 3.9 | 0.37 |
| PRIMARY Percent Change From Baseline to Post Intervention on Dual Task Cost to Standing Postural Sway Speed |
-23.1; 16.5; -11.5; 15.3 | 0.004 sig |
| SECONDARY Percent Change From Baseline to Post Intervention on Geriatric Depression Scale (GDS) Score |
10.5; -12.9; 27.3; -2.4 | 0.37 |
| SECONDARY Percent Change From Baseline to Post Intervention on Trial Making Test (TMT) |
-65.8; -17.1; -38.1; -17.2 | 0.54 |
| SECONDARY Percent Change From Baseline to Post Intervention on Dual-task Cost to Standing Sway Area |
-32.9; 51.1; -34.4; 211.8 | 0.0007 sig |
| SECONDARY Percent Change From Baseline to Post Intervention on Dual Task Cost to Stride Time in 24-meter Walking Test |
-25.7; 83.8; -16.3; 57.0 | 0.04 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02436915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.