N/A
N=10
Transcranial Direct Current Stimulation (tDCS)
Brain Fog
Bottom Line
View on ClinicalTrials.gov: NCT05524233 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score) — 30.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Transcranial Direct Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score) |
30.5 | — |
| PRIMARY Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score) |
22.5 | — |
| PRIMARY Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score) |
9 | — |
| SECONDARY Change in Digit Memory Test Average Score at 4 Weeks Compared to Baseline |
2.5 | — |
| SECONDARY Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline |
45.8 | — |
| SECONDARY Changes in Trail Making Task (TMT) From Baseline |
-0.9; -4.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05524233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.