Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05270408

Collaborator

(none)

500

Enrollment

Location

Arms

52.8

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Mild Cognitive Impairment Dementia	Device: Active Transcranial direct current stimulation (STARStim 8) Device: Active Transcranial direct current stimulation (STARStim 8) Device: Sham Transcranial direct current stimulation (STARStim 8)	N/A

Detailed Description

This is a pilot study being done to attempt to improve verbal episodic memory in persons with mild cognitive impairment (MCI) and dementia. Although the hippocampus is a brain structure most often associated with early deficits in MCI and dementia, the pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (DACC) have been shown to play a role in verbal episodic memory for such patients. 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 verbal episodic memory in patients with MCI and dementia. Entraining the preSMA/DACC circuit with 10 sessions at one of two levels of HD-tDCS will allow the researchers to investigate whether neuromodulation may be used to improve verbal episodic memory. Participants will receive 10 sessions at one of two levels of active stimulation (1 mA or 2 mA anodal HD-tDCS targeting preSMA/DACC for 20 min) or sham across 2 weeks. The device is used to deliver high definition transcranial direct current stimulation to targeted regions. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. The investigators plan to recruit English-speaking participants aged 50 years and older with MCI and dementia. Participants will be randomized into HD-tDCS conditions.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia

Actual Study Start Date :

Aug 8, 2022

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active stimulation at 1mA Participants will receive 1 mA active HD-tDCS for 20 minutes.	Device: Active Transcranial direct current stimulation (STARStim 8) Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.
Experimental: Active stimulation at 2mA Participants will receive 2 mA active HD-tDCS for 20 minutes.	Device: Active Transcranial direct current stimulation (STARStim 8) Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.
Sham Comparator: Sham group Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.	Device: Sham Transcranial direct current stimulation (STARStim 8) Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.

Arm

Intervention/Treatment

Experimental: Active stimulation at 1mA

Participants will receive 1 mA active HD-tDCS for 20 minutes.

Device: Active Transcranial direct current stimulation (STARStim 8)

Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.

Experimental: Active stimulation at 2mA

Participants will receive 2 mA active HD-tDCS for 20 minutes.

Device: Active Transcranial direct current stimulation (STARStim 8)

Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.

Sham Comparator: Sham group

Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.

Device: Sham Transcranial direct current stimulation (STARStim 8)

Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.

Outcome Measures

Primary Outcome Measures

Change in Score on the Rey Auditory Verbal Learning Test (RAVLT) [Baseline, immediately following last treatment session, and 2-months post treatment]
The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 50 and older
Fluent in English
Active diagnosis of MCI or dementia

Exclusion Criteria:

Substance use disorder
Has metal fragments in head
Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)