Noninvasive Brain Stimulation for Mild Cognitive Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with amnestic mild cognitive impairment (aMCI), a condition affecting memory, particularly in those with a history of traumatic brain injury (TBI). The technique, High Definition Transcranial Direct Current Stimulation (HD-tDCS), involves gentle electrical stimulation to the brain to determine its potential to improve memory. Participants will receive either the active treatment or a sham (placebo) version for comparison. Suitable candidates have a current aMCI diagnosis, a history of TBI, and experience memory problems. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatments for memory issues.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that could interact with the treatment, like amphetamines or L-dopa. It's best to discuss your current medications with the trial team to see if any changes are needed.
What prior data suggests that this method is safe for patients with mild cognitive impairment?
Research has shown that High Definition Transcranial Direct Current Stimulation (HD-tDCS) is generally safe for people. In past studies, most participants felt little to no sensation during the sessions, whether they received the actual treatment or a placebo.
One study found that HD-tDCS was well-tolerated by individuals with mild memory problems, with most experiencing no serious issues or discomfort.
Overall, evidence suggests that HD-tDCS is safe for humans, with only mild side effects, if any.12345Why are researchers excited about this trial?
Researchers are excited about High Definition Transcranial Direct Current Stimulation (HD-tDCS) for mild cognitive impairment because it offers a noninvasive way to potentially enhance brain function. Unlike current treatments that often rely on medications, HD-tDCS uses a mild electrical current to stimulate specific brain regions, aiming to improve memory and cognitive abilities. This method targets the dorsal anterior cingulate region, which plays a crucial role in cognitive processes. The promise of HD-tDCS lies in its ability to deliver targeted brain stimulation without the side effects associated with drugs, making it an innovative approach in cognitive health.
What evidence suggests that high definition transcranial direct current stimulation is effective for improving episodic memory in mild cognitive impairment?
In this trial, participants will receive either active high-definition transcranial direct current stimulation (HD-tDCS) or sham HD-tDCS. Research has shown that HD-tDCS can assist individuals with mild cognitive impairment, often characterized by memory problems. Studies have found that HD-tDCS might enhance thinking skills by delivering a small electrical current to the brain, targeting the area involved in memory and attention. Specifically, one study noted improved learning and memory after several HD-tDCS sessions. Participants reported enhanced memory immediately after the treatment and even weeks later. These findings suggest that HD-tDCS could be promising for boosting memory in individuals with mild cognitive issues and a history of traumatic brain injury.16789
Are You a Good Fit for This Trial?
This trial is for individuals aged 50 or older, who are native English speakers with at least a high school education. Participants must have mild cognitive impairment due to past traumatic brain injury (TBI), but not within the last two years. They can't join if they've had major cardiovascular events, epilepsy, severe psychiatric disorders, substance use disorder, metal in the head, or take certain medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 10 sessions of HD-tDCS or sham stimulation targeting the dorsal anterior cingulate region over 2 weeks
Immediate Follow-up
Episodic memory tasks are completed immediately following the last HD-tDCS session
3-Month Follow-up
Participants are monitored for episodic memory improvements and other cognitive measures
What Are the Treatments Tested in This Trial?
Interventions
- High Definition Transcranial Direct Current Stimulation
- Sham HD-tDCS
Trial Overview
The study tests whether ten sessions of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on a specific brain area improve memory in people with cognitive issues from past TBI. Memory will be checked after treatment and three months later.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
Participants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
High Definition Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:
- Investigational for various neurological conditions, including depression, chronic pain, and cognitive enhancement
- Investigational for various neurological conditions, including depression, chronic pain, and cognitive enhancement
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
U.S. Army Medical Research and Development Command
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Citations
A randomized, triple-blind, sham-controlled trial
Effectiveness and safety of high-definition transcranial direct current stimulation in patients with mild cognitive impairment: A randomized, ...
The Effects of Transcranial Direct Current Stimulation in ...
Numerous studies have shown that tDCS can have several useful effects in patients with MCI. It is believed to enhance cognitive functions, ...
High definition transcranial direct current stimulation as an ...
Cognitive outcomes were measured at baseline, after the last HD-tDCS session, and 8-weeks post-treatment. The primary outcome was change in total learning ...
High Definition Transcranial Direct Current Stimulation (HD ...
Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia; CDR score ≤ 2; Subject under treatment by IAChE for at ...
High Definition Transcranial Direct Current Stimulation (HD ...
This program and training model have been demonstrated to be effective and beneficial in patients with vascular cognitive impairment. In the CCT ...
A randomized, triple-blind, sham-controlled trial
HD-tDCS did not enhance global cognition in MCI patients overall. Preliminary findings demonstrated a potential language benefit was observed in ...
Tolerability and blinding of high-definition transcranial ...
HD-tDCS was well tolerated with mostly no (“none”) or “mild” sensations reported across sessions, regardless of active or sham condition and in both stimulation ...
Noninvasive Brain Stimulation in Mild Cognitive ...
The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its ...
Safety and feasibility of optimized transcranial direct ...
This study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode positions in patients with ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.