Brain Stimulation and Enhancing Cognition in Older Adults

NCT03653351 | Completed Results FDA Device

• 1 other identifier: ID#201805097
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cognitive Impairment, Mild; Depressive Symptoms; Anxiety

Outcome Measures

Primary Outcomes (1)

• Cognitive and Memory Function

  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 in general functioning. Fluid abilities are used to solve problems, think and act quickly, and encode new episodic memories. They are presumed to be especially influenced by biological processes and are less dependent on past exposure (learning experiences). There is only one primary outcome. No secondary outcomes were reported.

  8 weeks

Study Arms (2)

Sham tDCS and MBSR

SHAM COMPARATOR

Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.

Device: Sham Transcranial Direct Current Stimulation (tDCS)

Active tDCS and MBSR

ACTIVE COMPARATOR

Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.

Device: Active Transcranial Direct Current Stimulation (tDCS)

Interventions

Active Transcranial Direct Current Stimulation (tDCS) DEVICE

Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol.

Active tDCS and MBSR

Sham Transcranial Direct Current Stimulation (tDCS) DEVICE

Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes).

Sham tDCS and MBSR

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \<25 or SBT 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Brooks H, Oughli HA, Kamel L, Subramanian S, Morgan G, Blumberger DM, Kloeckner J, Kumar S, Mulsant BH, Lenze EJ, Rajji TK. 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. Mindfulness (N Y). 2021;12(12):3047-3059. doi: 10.1007/s12671-021-01764-9. Epub 2021 Oct 5.

  PMID: 34630733 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Some of the strengths of this feasibility study were a broad range of outcome measures assessing mindfulness, but also cognition, anxiety, depression, and social function; and the length and duration of the tDCS stimulation (10 weeks) that was longer than in most previous studies. The main limitation was the small sample size, which increases the likelihood of both false negative and false positive findings.

Results Point of Contact

• Title: Eric Lenze MD
• Organization: Washington University in Saint Louis

lenzee@wustl.edu

314-362-5154

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 31, 2018
• Study Start: June 27, 2018
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: July 8, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)