Noninvasive Brain Stimulation for Mild Cognitive Impairment

Summary

The goal of this study is to test the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Mild Cognitive Impairment (MCI). Participants will be randomly assigned to one of three treatment groups: Group 1: Active Dorsolateral Prefrontal Cortex (DLPFC) rTMS; Group 2: Active Lateral Parietal Cortex (LPC) rTMS; and Group 3: Inactive rTMS (Placebo) control (evenly split between each coil location). Participation in the study takes approximately 7 ½ months-including a 2-to 4-week treatment phase (20 rTMS sessions) and a 6-month follow-up phase.

Conditions

• Mild Cognitive Impairment
• Mild Neurocognitive Disorder
• Cognitive Decline
• Mental Deterioration
• Cognitive Dysfunction
• Memory Decline
• Memory Loss
• Memory Impairment

Interventions

DEVICE

Active rTMS (Bilateral DLPFC)

TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).

DEVICE

Active rTMS (Bilateral LPC)

TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).

DEVICE

Placebo rTMS (Inactive)

For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Palo Alto Veterans Institute for Research

  lead OTHER

Principal Investigators

• Joy L Taylor, Ph.D. · Stanford/VA Aging Clinical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-15

Primary Completion

2022-12-19

Completion

2023-03-28

FDA Device

Yes

Countries

• United States

Study Locations