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Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia

Primary Purpose

Alzheimer Disease, Mild Cognitive Impairment, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial direct current stimulation (STARStim 8)
Active Transcranial direct current stimulation (STARStim 8)
Sham Transcranial direct current stimulation (STARStim 8)
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Transcranial direct current stimulation, Alzheimer Disease, Mild Cognitive Impairment, Dementia, MCI, Mild neurocognitive disorder, Amnestic, Pre- alzheimer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 50 and older
  2. Fluent in English
  3. Active diagnosis of MCI or dementia

Exclusion Criteria:

  1. Substance use disorder
  2. Has metal fragments in head
  3. 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)

Sites / Locations

  • UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Active stimulation at 1mA

Active stimulation at 2mA

Sham group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
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.

Secondary Outcome Measures

Full Information

First Posted
December 30, 2021
Last Updated
September 26, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05270408
Brief Title
Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia
Official Title
Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mild Cognitive Impairment, Dementia
Keywords
Transcranial direct current stimulation, Alzheimer Disease, Mild Cognitive Impairment, Dementia, MCI, Mild neurocognitive disorder, Amnestic, Pre- alzheimer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation at 1mA
Arm Type
Experimental
Arm Description
Participants will receive 1 mA active HD-tDCS for 20 minutes.
Arm Title
Active stimulation at 2mA
Arm Type
Experimental
Arm Description
Participants will receive 2 mA active HD-tDCS for 20 minutes.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.
Intervention Type
Device
Intervention Name(s)
Active Transcranial direct current stimulation (STARStim 8)
Intervention Description
Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.
Intervention Type
Device
Intervention Name(s)
Active Transcranial direct current stimulation (STARStim 8)
Intervention Description
Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial direct current stimulation (STARStim 8)
Intervention Description
Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.
Primary Outcome Measure Information:
Title
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
Description
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.
Time Frame
Baseline, immediately following last treatment session, and 2-months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Neaves, MA
Phone
214-865-9508
Email
Stephanie.Neaves@utsw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Cabrera, MS
Phone
214-865-9508
Email
Hannah.Cabrera@utsw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian LoBue, PhD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian LoBue, Ph.D.
Email
christian.lobue@utsouthwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia

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