Cognitive Impairment, MildNCT03653351

Brain Stimulation and Enhancing Cognition in Older Adults

A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Cognitive Impairment, Mild and Depressive Symptoms, run by Washington University School of Medicine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Cognitive Impairment, Mild, Depressive Symptoms, Anxiety
What is being tested?: Active Transcranial Direct Current Stimulation (tDCS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 2 sitesUnited States
Study dates: 27 Jun 2018to 22 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Washington University in Saint Louis
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Enhancing Cognition in Older Persons: A Randomized Controlled Trial of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS).

Read the 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.

Conditions: Cognitive Impairment, Mild, Depressive Symptoms, Anxiety
Being tested: Active Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
Medical subject headings: Cognitive Dysfunction, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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).

Study groups in NCT03653351
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Active Transcranial Direct Current Stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 201822 Apr 2019

First posted31 Aug 2018
Study start27 Jun 2018
Primary completion22 Apr 2019
Study completion22 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03653351
Sponsor's protocol ID: ID#201805097
Status last verified: Jul 2021
First submitted: 25 Jul 2018
Last updated: 8 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 34630733

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Cognition in Older Persons: A Randomized Controlled Trial of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS).
ClinicalTrials.gov ID: NCT03653351
Acronym / sponsor ID: ID#201805097
Conditions: Cognitive Impairment, Mild, Depressive Symptoms, Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 27 Jun 2018 (actual)
Primary completion: 22 Apr 2019 (actual)
Study completion: 22 Apr 2019 (actual)
First posted: 31 Aug 2018 (actual)
Results: Posted 29 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham tDCS and MBSR	Sham comparator	Device: Sham Transcranial Direct Current Stimulation (tDCS)Includes a combination of 8 weeks of in-class group MBSR + sham tDCS and daily at home MBSR + sham tDCS.
Active tDCS and MBSR	Active comparator	Device: Active Transcranial Direct Current Stimulation (tDCS)Includes a combination of 8 weeks of in-class group MBSR + active tDCS and daily at home MBSR + active tDCS.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Active tDCS and MBSR
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).	Device	Sham tDCS and MBSR

Primary outcome

Cognitive and Memory Function
Time frame: 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 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.

Results and safety

Results posted to the registry on 29 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham tDCS and MBSR	14	13
Active tDCS and MBSR	12	10

Primary outcome: Cognitive and Memory Function

Time frame: 8 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Sham tDCS and MBSR n = 14	Active tDCS and MBSR n = 12
Value	56.5 (6.7)	49.8 (7.2)

Population analysed: Twenty-six participants enrolled in the study: 14 were randomized to sham tDCS and 12 to active tDCS.

Adverse events

Time frame: Eight weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham tDCS and MBSR	0 of 14 (0%)	7 of 14 (50%)	0 of 14
Active tDCS and MBSR	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34630733Brooks 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive and Memory Function (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03653351, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.