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

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.

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.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Rey Auditory Verbal Learning Test Score

Secondary study objectives

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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