NCT03653351

Brain Stimulation and Enhancing Cognition in Older Adults

Completed NA Results posted Last updated 8 July 2021

What this trial tests

NA trial testing Active Transcranial Direct Current Stimulation (tDCS) in Cognitive Impairment, Mild in 26 participants. Completed in 22 April 2019.

Timeline

27 June 2018

Primary endpoint
22 April 2019

22 April 2019

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	26
Start date	27 June 2018
Primary completion	22 April 2019
Estimated completion	22 April 2019
Sites	2 locations across United States

Drugs / interventions tested

• Active Transcranial Direct Current Stimulation (tDCS)
• Sham Transcranial Direct Current Stimulation (tDCS)

Conditions studied

• Cognitive Impairment, Mild — all drugs for Cognitive Impairment, Mild →
• Depressive Symptoms — all drugs for Depressive Symptoms →
• Anxiety — all drugs for Anxiety →

Sponsor

Washington University School of Medicine

Who can join

60 and older, any sex, with Cognitive Impairment, Mild or Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cognitive and Memory Function Primary · 8 weeks

NIH Toolbox Fluid Cognition Composite Score: provides a global assessment of general fluid cognition functioning. Higher scores indicate higher levels of cognitive functioning. A score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average cognitive ability, while scores around 130 suggest superior ability ( in the top 2 percent nationally). Conversely, a score around 85 suggests below-average cognitive ability and a score in the range of 70 or below suggests significant impairment, which may also be indicative of difficulties

Group	Value	95% CI
Sham tDCS and MBSR	56.5	± 6.7
Active tDCS and MBSR	49.8	± 7.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Eight weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sham tDCS and MBSR

Serious: 0/14 (0%)

Deaths: 0/14

Active tDCS and MBSR

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (1 terms — click to expand)

Reaction	System	Sham tDCS and MBSR	Active tDCS and MBSR
Burning and tingling of scalp	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03653351 adverse events section.

Sponsor's own description

The aim of the current research is to evaluate the efficacy of a combination of Mindfulness-Based Stress Reduction (MBSR) and transcranial direct current stimulation (tDCS) to improve cognitive function in individuals with anxiety, depression and/or cognitive complaints.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enhancing Cognition in Older Persons with Depression or Anxiety with a Combination of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS): Results of a Pilot Randomized Clinical Trial.
   Brooks H, Oughli HA, Kamel L, Subramanian S, et al · · 2021 · cited 24× · PMID 34630733 · DOI 10.1007/s12671-021-01764-9