N/A
N=26
Brain Stimulation and Enhancing Cognition in Older Adults
Cognitive Impairment, Mild · Depressive Symptoms · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03653351 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Cognitive and Memory Function — 56.5; 49.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Transcranial Direct Current Stimulation (tDCS) (Device); Sham Transcranial Direct Current Stimulation (tDCS) (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive and Memory Function |
56.5; 49.8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Community-dwelling men and women aged 60 or above.
- Current cognitive complaints per participant self-report, but with intact cognitive function as defined by a score of 0-9 on the Short Blessed Test (SBT) and a Montreal Cognitive Assessment (MoCA) score ≥25 per PI discretion.
- PROMIS depression scale score of greater or equal to 16 and/or PROMIS anxiety score greater or equal to 14.
- Ability to read and speak English fluently enough to complete all research assessments.
- Corrected visual ability to read newspaper headlines.
- Hearing capacity to respond to a raised conversational voice.
- Willingness and ability to provide informed consent.
Exclusion Criteria
- The Mini-International Neuropsychiatric Interview (MINI) criteria for current or life-time bipolar disorder, schizophrenia, schizoaffective disorder.
- Untreated current post-traumatic stress disorder.
- A MoCA score 9, per PI discretion.
- Use of cognitive enhancers (namely, cholinesterase inhibitors such as donepezil; or memantine) within the past 6 weeks.
- MINI criteria for any substance abuse within 6 months that would affect their participation, per PI discretion.
- Unstable medical illness (e.g. uncontrolled diabetes mellitus or hypertension).
- Concurrent cognitive training, such as brain-training software, participation in psychotherapy or regular engagement in mindfulness practice and/or yoga.
- Taking anticonvulsant or antipsychotics that cannot be safely tapered and discontinued.
Data sourced from ClinicalTrials.gov (NCT03653351). 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.