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Brain Stimulation
Brain Stimulation for Dementia (COBALT Trial)
N/A
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment
Awards & highlights
Summary
This trial is testing whether high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/dACC region can help improve episodic memory and word recall in patients with mild cognitive impairment (MCI) or dementia.
Who is the study for?
This trial is for individuals aged 55 or older who are fluent in English and have been diagnosed with mild cognitive impairment or dementia. It's open to all genders and ethnicities. People can't join if they've had major neurological conditions, substance use disorders within the last year, metal fragments in their head, sensory impairments affecting testing, or take medications that affect brain stimulation.Check my eligibility
What is being tested?
The study tests whether a brain stimulation device called NeuroElectric StarStim can improve memory and language in people with memory problems due to MCI or dementia. Participants will receive either real neurostimulation targeting specific brain areas or a sham (fake) treatment as part of the research.See study design
What are the potential side effects?
Possible side effects from HD-tDCS may include discomfort at the electrode site, itching, tingling during application, headache, fatigue, nausea. The sham treatment should not cause any side effects since it mimics the actual procedure without active stimulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Rey Auditory Verbal Learning Test Score
Secondary outcome measures
Changes in Boston Naming Test Short Form
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Phase 2: Active TreatmentActive Control1 Intervention
For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months from completing Phase 1. They will receive the active treatment while being unblinded to their treatment condition. Following 10 active treatment sessions, word retrieval and other cognitive tasks will again be completed immediately following the last HD-tDCS session and then a 2-month follow-up.
Group II: Phase 1: Active TreatmentActive Control1 Intervention
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up
Group III: Phase 1: Sham TreatmentPlacebo Group1 Intervention
Participants will receive 10 sessions of sham stimulation across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,058 Previous Clinical Trials
1,045,124 Total Patients Enrolled
TEXAS ALZHEIMER'S RESEARCH & CARE CONSORTIUMUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication that affects brain stimulation treatments.I have been diagnosed with mild cognitive impairment or dementia.I am either a man or a woman.I am 55 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Sham Treatment
- Group 2: Phase 2: Active Treatment
- Group 3: Phase 1: Active Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05564715 — N/A
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