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Transcranial Direct Current Stimulation (tDCS) (tDCS)

Primary Purpose

Brain Fog

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial Direct Stimulation
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Brain Fog focused on measuring Cognitive impairment, Brain fog, Transcranial stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Direct Stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility and acceptability after 4 weeks of daily tDCS use
Feasibility and acceptability of tDCS will be assessed using a validated Technology Acceptance Model (TAM) questionnaire. Participants will provide information on how strongly they agree or disagree with statements regarding benefits, acceptability, and ease of the wearable device on a 7-point scale: 1) strongly disagree; 2) somewhat disagree; 3) disagree; 4) neutral; 5) agree; 6) somewhat agree; and 7) strongly agree. The TAM has a range from 16 (least agreeable) to 112 (more agreeable).

Secondary Outcome Measures

Full Information

First Posted
August 30, 2022
Last Updated
May 4, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05524233
Brief Title
Transcranial Direct Current Stimulation (tDCS)
Acronym
tDCS
Official Title
Transcranial Direct Current Stimulation (tDCS) For Improvement Of Cognitive Functioning, Brain Fog, And Working Memory
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Fog
Keywords
Cognitive impairment, Brain fog, Transcranial stimulation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will be part of the intervention group
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active Transcranial Direct Stimulation
Intervention Description
Subjects will receive a stimulation device to use up to 20 minutes daily for 4 weeks.
Primary Outcome Measure Information:
Title
Feasibility and acceptability after 4 weeks of daily tDCS use
Description
Feasibility and acceptability of tDCS will be assessed using a validated Technology Acceptance Model (TAM) questionnaire. Participants will provide information on how strongly they agree or disagree with statements regarding benefits, acceptability, and ease of the wearable device on a 7-point scale: 1) strongly disagree; 2) somewhat disagree; 3) disagree; 4) neutral; 5) agree; 6) somewhat agree; and 7) strongly agree. The TAM has a range from 16 (least agreeable) to 112 (more agreeable).
Time Frame
At 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Transcranial Direct Current Stimulation (tDCS)

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