CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled / 27 target
Drug / intervention
NeuroElectric StarStim +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05564715
NCT05564715N/ACompletedOn Track (0.7/mo)Completion was 12mo ago
CompareCT.gov

Cognitive Outcomes of Brain Stimulation As a Later-in-Life Treatment

University of Texas Southwestern Medical Center·interventional·Posted Oct 3, 2022·Updated Jun 12, 2026

In Brief

A clinical study evaluating NeuroElectric StarStim and Sham Treatment for Mild Cognitive Impairment and Amnestic Mild Cognitive Impairment - aMCI. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This is a pilot study being done to attempt to improve episodic memory problems in persons with mild cognitive impairment (MCI). The pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (dACC) have been shown to play a role in episodic memory and language retrieval. Prior studies have suggested that neurostimulation targeting this region can improve episodic memory and word recall. 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 influence on word retrieval and other cognitive functions in patients with MCI. Entraining the preSMA/dACC circuit with 10 sessions of HD-tDCS will allow us to study whether neurostimulation may be an effective treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment, Amnestic Mild Cognitive Impairment - aMCI
CountriesUnited States
CollaboratorsTexas Alzheimer's Research and Care Consortium

Timeline

N/ACompletedFinished
2023202420252026
First PostedOct 3, 2022
Enrollment StartMay 1, 2023
Primary CompletionJun 3, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 3.7 years ago

Arms & Interventions

Phase 1: Active Treatmentactive_comparator

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

Device: NeuroElectric StarStim
Phase 1: Sham Treatmentsham_comparator

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

Device: Sham Treatment
Phase 2: Active Treatmentactive_comparator

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.

Device: NeuroElectric StarStim

Interventions

NeuroElectric StarStimdevice

10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks

Sham Treatmentdevice

Sham stimulation for 10 sessions over 2 weeks