Clinical trial NCT05524233: Transcranial Direct Current Stimulation (tDCS)
Official title: Transcranial Direct Current Stimulation (tDCS) For Improvement Of Cognitive Functioning, Brain Fog, And Working Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Fog
Keywords: Cognitive impairment
Brain fog
Transcranial stimulation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be part of the intervention group
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Cognitive impairment refers to when an individual struggles to learn, concentrate, remember, or make decisions. This can be due to underlying neurological diseases (i.e. Alzheimer's disease, dementia, etc.), caused by viral illness (i.e. brain fog experienced by COVID-19 survivors) or physical trauma (i.e. concussion). Recent reports indicate that two out of three Americans experience some amount of cognitive impairment in their lifetime.

There are a number of therapies that have been used to help address this condition. One of these is transcranial direct current stimulation (tDCS), which delivers sustained direct current to to the head area via electrodes. A number of studies have indicated that this form of therapy is safe and efficacious at inducing neuroplasticity and exciting neuronal activity. These factors can help improve aspects of cognitive functioning such as working memory, learning, and task performance.

The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless, transcranial direct current stimulation for people with cognitive impairments.

Detailed description: Sample size (n=10) is convenient and designed to explore acceptability and feasibility. Participants who are enrolled will be provided a tDCS device to use for a period of four weeks. They will have two study visits, baseline (BL) and the 4th week visit (W4). During each visit participants will answer various questionnaires to assess patient-reported outcomes such as sleep quality, cognitive impairment, depression, anxiety, fatigue, and user acceptability.

The entire cohort will receive a transcranial direct stimulation (tDCS) device which uses LIFTiD Neurostimulation technology (RPW TECHNOLOGY, LLC, New York, USA). Participants will take the device home and daily, they will use the device for a maximum of 20 minutes to stimulate neuroplasticity. During the stimulation period they will be asked to perform a light activity such as reading, checking emails, etc. The participants will return to the McNair Campus for their final visit after 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Adults (aged 18+) suffering from poor working memory, brain fog, or cognitive impairments (such as dementia, Alzheimer's, concussions, etc); ability to attend to the clinic for visits

Exclusion Criteria:

* Severe cognitive decline that reduces their ability to interact with the tDCS device; Major visual or hearing weakness reduces the ability to interact with tDCS device; Major foot problems such as active lower extremity wounds, major foot deformity (e.g., Charcot Foot), previous major amputations, and claudication; Demand-type cardiac pacemaker, implanted defibrillator, implanted metal plate in the brain or head, or other implanted electronic devices; Epilepsy, seizures, brain lesions, or severe heart disease; Sensitive skin or rash, broken skin, or open wounds; Pregnancy; and any conditions that may interfere with outcomes or increase the risk of the use tDCS based on the judgement of clinicians

Primary outcomes:
measure: Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score)
timeFrame: At 4 weeks
measure: Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score)
timeFrame: At 4 weeks
measure: Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score)
timeFrame: At 4 weeks
Secondary outcomes:
measure: Change in Digit Memory Test Average Score at 4 Weeks Compared to Baseline
timeFrame: Baseline - 4 weeks
measure: Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline
timeFrame: Baseline - 4 weeks
measure: Changes in Trail Making Task (TMT) From Baseline
timeFrame: Baseline - 4 weeks
Other outcomes:
measure: Change in MoCA Score at 4 Weeks Compared to Baseline
timeFrame: Baseline - 4 weeks
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: