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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

COBALT Trial 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.

COBALT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment for reporting.

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

COBALT 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

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,043,800 Total Patients Enrolled
TEXAS ALZHEIMER'S RESEARCH & CARE CONSORTIUMUNKNOWN

Media Library

NeuroElectric StarStim (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05564715 — N/A
Mild Cognitive Impairment Research Study Groups: Phase 1: Sham Treatment, Phase 2: Active Treatment, Phase 1: Active Treatment
Mild Cognitive Impairment Clinical Trial 2023: NeuroElectric StarStim Highlights & Side Effects. Trial Name: NCT05564715 — N/A
NeuroElectric StarStim (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05564715 — N/A
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05564715 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this research project striving to accomplish?

"Investigating the primary outcome of this clinical trial, which will span pre-treatment to 8 weeks post-treatment, is Changes in Rey Auditory Verbal Learning Test Score. Secondary outcomes involve assessing Changes in Boston Naming Test Short Form (ranging from 0-30 with higher scores indicating better performance) and Delis Kaplan Executive Function System Verbal Fluency Test (0-no upper limit for each trial). For both of these measures changes are measured between baseline and immediately after condition completion as well as between baseline and 8 months post-treatment."

Answered by AI

Is enrollment for this experiment currently underway?

"Clinicaltrials.gov indicates that this particular medical trial, initially posted on the 1st of November 2022 and last updated 18th October 2022, is no longer seeking participants. Nonetheless, 887 other clinical trials are currently taking candidates."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

MCI and getting worse. My MCI has become a problem.
PatientReceived 2+ prior treatments
~6666 spots leftby Sep 2026