Clinical trial NCT03034954: Patient Centered-Rehabilitation ver111090.1
Official title: Effects of 3mA HD-tDCS on Associative and Working Memory in Cognitively Intact Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects of TES on working memory, learning, and memory, will be evaluated in a group of healthy older adults.

Detailed description: The primary objective is to investigate the cognitive effects of high definition anodal tDCS (HD-tDCS; anode at center electrode) at 3 mA (for 20 minutes) on learning, memory, and working memory. Participants will be randomized to active or sham stimulation and will complete a series of cognitive tests both during and after stimulation.

Tolerability and blinding will also be evaluated using standard side effect questionnaires.

Eligibility criteria: Inclusion Criteria:

1. Individuals with intact cognitive functioning.
2. Participants will be age 50 or older.

Exclusion Criteria:

1. Individuals with a documented history of cognitive impairment.
2. A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders)
3. Sensory or motor impairments that limit the ability to take part in the study
4. A significant history or current use of alcohol or drug abuse/dependence
5. Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)
6. Participants with an Mini Mental State Examination score \<24 at screening.

Primary outcomes:
measure: Object Location Touchscreen Task (Version C) Free Recall Total Error
timeFrame: 15 minutes after encoding
measure: Object Location Touchscreen Task (Version C) Free Recall Average Error
timeFrame: 15 minutes after encoding
measure: Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond
timeFrame: 15 minutes after encoding
measure: Object Location Touchscreen Task (Version C) Cued Recall Total Error
timeFrame: 15 minutes after encoding
measure: Object Location Touchscreen Task (Version C) Cued Recall Average Error
timeFrame: 15 minutes after encoding
measure: Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond
timeFrame: 15 minutes after encoding
measure: Object Location Touchscreen Task (Version C) Recognition Total Correct
timeFrame: 15 minutes after encoding
measure: Object Location Touchscreen Task (Version C) Recognition Average Time to Respond
timeFrame: 15 minutes after encoding
measure: Performance (d') on a Simple Attention (0-back) Test
timeFrame: 30 minutes post-stimulation
measure: Performance (d') on a Working Memory (2-back) Test
timeFrame: 30 minutes post-stimulation
measure: Performance (d') on a Working Memory (Semantic 2-back) Test
timeFrame: 30 minutes post-stimulation
measure: Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')
timeFrame: 30 minutes post-stimulation
measure: Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')
timeFrame: 30 minutes post-stimulation
Secondary outcomes:
measure: Blinding in Total Sample
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
measure: Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
timeFrame: ~1 minute post stimulation
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan - Department of Psychiatry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Benjamin M Hampstead, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.