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Brain Stimulation and Enhancing Cognition in Older Adults

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ClinicalTrials.gov Identifier: NCT03653351
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment, Mild Depressive Symptoms Anxiety Device: Active Transcranial Direct Current Stimulation (tDCS) Device: Sham Transcranial Direct Current Stimulation (tDCS) Not Applicable

Detailed Description:

Neurocognitive difficulties are a common problem in the older adult population. Previous research has shown memory complaints are higher in older adults with depression or anxiety versus those without these diagnoses. This suggests that mood symptoms, or a diagnosis of a mood disorder, may represent significant predictors of cognitive impairment. If left untreated, symptoms of depression and memory complaints may lead to greater cognitive impairment, i.e. Mild Cognitive Impairment (MCI) and diagnosis of dementia. Therefore, early interventions are urgently needed to prevent decline in memory and cognitive function in individuals with MCI, depression and/or anxiety.

Ideal interventions for the older aged population would be those that are easily accessible and associated with minimal burden on family members, the healthcare system and the individuals themselves. Mindfulness- Based Stress Reduction (MBSR) therapy and Transcranial Direct Current Stimulation (tDCS) are two interventions that may be effective in targeting cognitive deficits in individuals with anxiety, depression and/ or cognitive complaints. MBSR has been shown to decrease symptoms of depression and improve cognition and tDCS has been shown to improve cognition in the older aged population. The effectiveness of these two interventions combined to elicit changes in cognition has yet to be demonstrated. Therefore, the overall aim of the current research is to evaluate the efficacy of a combination of MBSR and tDCS to improve cognitive function in individuals with anxiety, depression and/or cognitive complaints.

This will be a randomized pilot study. Sixteen individuals (separated into 2 groups of 8) will be randomized to receive a combination of MBSR + active tDCS or MBSR + sham tDCS over 8 weeks. Participants will visit the Healthy Mind Lab once per week for in-class group sessions and will complete the intervention daily at home for the duration of the study. Participants will be aged 60 and older with cognitive complaints, with or without symptoms of anxiety and/or depression. Participants will be trained to self-administer tDCS and given guidelines for the completion of daily MBSR activities at home. It is hypothesized that the combination of active tDCS+MBSR will enhance cognition compared to the combination of sham tDCS + MBSR.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Cognition in Older Persons: A Randomized Controlled Trial of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS).
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Sham Comparator: Sham tDCS and MBSR
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)
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).

Active Comparator: Active tDCS and MBSR
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)
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.




Primary Outcome Measures :
  1. Cognitive and memory function [ Time Frame: 8 weeks ]
    Cognitive and memory function measured by neuropsychological battery examining memory, executive functioning and attention


Secondary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) depressive symptoms [ Time Frame: 8 weeks ]
    Depression symptoms are assessed via scales of self - report NIH Patient-Reported Outcomes Measurement Information System (PROMIS) > 15 for depression

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety symptoms [ Time Frame: 8 weeks ]
    Anxiety symptoms are assessed via scales of self - report NIH Patient-Reported Outcomes Measurement Information System (PROMIS) > 13 for anxiety



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Community-dwelling men and women aged 60 or above.
  2. 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.
  3. PROMIS depression scale score of greater or equal to 16 and/or PROMIS anxiety score greater or equal to 14.
  4. Ability to read and speak English fluently enough to complete all research assessments.
  5. Corrected visual ability to read newspaper headlines.
  6. Hearing capacity to respond to a raised conversational voice.
  7. Willingness and ability to provide informed consent.

Exclusion Criteria:

  1. The Mini-International Neuropsychiatric Interview (MINI) criteria for current or life-time bipolar disorder, schizophrenia, schizoaffective disorder.
  2. Untreated current post-traumatic stress disorder.
  3. A MoCA score <25 or SBT score >9, per PI discretion.
  4. Use of cognitive enhancers (namely, cholinesterase inhibitors such as donepezil; or memantine) within the past 6 weeks.
  5. MINI criteria for any substance abuse within 6 months that would affect their participation, per PI discretion.
  6. Unstable medical illness (e.g. uncontrolled diabetes mellitus or hypertension).
  7. Concurrent cognitive training, such as brain-training software, participation in psychotherapy or regular engagement in mindfulness practice and/or yoga.
  8. Taking anticonvulsant or antipsychotics that cannot be safely tapered and discontinued.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653351


Contacts
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Contact: Hanadi Ajam Oughli, MD 314-267-7801 ajamoughli@wustl.edu
Contact: Julia Schweiger 314-362-3153 schweigj@wustl.edu

Locations
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United States, Missouri
Washington University in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Hanadi Ajam Oughli, MD    314-267-7801      
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Michelle Voegtle    314-362-6400    voegtlem@psychiatry.wustl.edu   
Contact: Julie Schweiger    314-362-5153    schweigj@psychiatry.wustl.edu   
Principal Investigator: Eric Lenze         
Sponsors and Collaborators
Washington University School of Medicine

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Responsible Party: Eric Lenze, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03653351     History of Changes
Other Study ID Numbers: ID#201805097
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Depression
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms