Transcranial Direct Current Stimulation (tDCS)

NCT05524233 | Completed Results

• 1 other identifier: 52200
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Fog

Keywords

Cognitive impairment; Brain fog; Transcranial stimulation

Outcome Measures

Primary Outcomes (3)

• Perceived Ease of Use After 4 Weeks of Daily tDCS Use (TAM Score)

  The perceived ease of use of tDCS will be assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire. Participants will rate the device on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) across seven questions. The total score will range from 7 (extremely difficult) to 35 (extremely easy), with higher scores indicating greater ease of use. Questions will assess: (1) ease of use, (2) sponge preparation, (3) attaching sponges, (4) starting/stopping therapy, (5) charging, (6) mobility while wearing the device, and (7) task completion during use. The TAM subscore will be calculated by summing individual scores, with median values reported as an overall measure of ease of use.

  At 4 weeks

• Perceived Usefulness After 4 Weeks of Daily tDCS Use (TAM Score)

  The perceived usefulness of tDCS was assessed using a subscore of the Technology Acceptance Model (TAM) questionnaire. Participants rated the usefulness of the device on a 5-point scale: 1 = Decreased Significantly, 2 = Decreased, 3 = Neutral, 4 = Increased, 5 = Increased Significantly. Six questions were used to assess overall perceived usefulness, focusing on benefits related to mental activity, energy levels, memory, attention, concentration, and alertness. The total score ranged from 6 (not at all useful) to 30 (highly useful), with higher values indicating greater perceived usefulness. The TAM subscore for perceived usefulness was calculated by summing the individual component scores and determining the median value across participants.

  At 4 weeks

• Attitude Towards Use After 4 Weeks of Daily tDCS Use (TAM Score)

  The attitude toward use of the tDCS device was assessed using a subscale of the Technology Acceptance Model (TAM) questionnaire. Participants will rate their attitude toward use on a 5-point Likert scale (1 = Extremely Difficult, 5 = Extremely Easy) based on two questions: (1) I would continue this therapy after completing the study, and (2) I would recommend this therapy to friends/family. The total score ranges from 2 (extremely difficult) to 10 (extremely easy), with higher scores reflecting a more positive attitude toward the device. The TAM subscore is calculated by summing individual component scores, with median values reported, providing an overall measure of perceived ease of use and intention to use.

  At 4 weeks

Secondary Outcomes (3)

• Change in Digit Memory Test Average Score at 4 Weeks Compared to Baseline

  Baseline - 4 weeks

• Change in Hopkins Verbal Learning Test Total Score at 4 Weeks Compared to Baseline

  Baseline - 4 weeks

• Changes in Trail Making Task (TMT) From Baseline

  Baseline - 4 weeks

Other Outcomes (1)

• Change in MoCA Score at 4 Weeks Compared to Baseline

  Baseline - 4 weeks

Study Arms (1)

Transcranial Direct Stimulation

EXPERIMENTAL

Subjects will receive an active electrical stimulation device (tDCS) to use up to 20 minutes daily for 4 weeks. To deliver tDCS subjects will place a strap around their forehead area.

Device: Active Transcranial Direct Stimulation

Interventions

Active Transcranial Direct Stimulation DEVICE

Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.

Transcranial Direct Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Mental Fatigue; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Five participants (out of 10 baseline participants) were withdrawn for the following reasons: loss to follow-up (n=2), headache (n=1), skin irritation (n=1), and withdrawal of consent due to concerns about potential side effects (n=1). Consequently, only five participants completed the 4-week therapy and were included in the final analysis.

Results Point of Contact

• Title: Bijan Najafi
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

7137987536

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Baylor College of Medicine

Model Details: All participants will be part of the intervention group

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: September 29, 2022
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-03

Locations

US (1)