CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
High-dose accelerated rTMSdevice
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/NCT04503096
NCT04503096N/ACompleted
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High-dose Accelerated Repetitive Transcranial Magnetic Stimulation to Cognitive Control Neurocircuitry in Mild Cognitive Impairment: A Safety and Feasibility Study

Medical University of South Carolina·interventional·Posted Aug 7, 2020·Updated Sep 7, 2023

In Brief

A clinical study evaluating High-dose accelerated rTMS for Mild Cognitive Impairment. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The goal of this pilot study is to determine whether a high-dose form of non-invasive brain stimulation is a promising and safe treatment for Mild Cognitive Impairment (MCI). Transcranial magnetic stimulation (TMS) is an FDA approved treatment for depression. In studies of TMS for depression and other disorders, individuals have experienced improved cognitive function. Thus, the current study is testing whether TMS is safe, feasible and effective in improving cognition in individuals with MCI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment
CountriesUnited States
CollaboratorsNational Center of Neuromodulation for Rehabilitation

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 7, 2020
Enrollment StartApr 12, 2021
Primary CompletionJun 29, 2022
Study CompletionJul 27, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.9 years ago

Interventions

High-dose accelerated rTMSdevice

A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System will be utilized. All participants will receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within an eight-day span. A single session = 600 pulses at 120% resting motor threshold (rMT), intermittent Theta Burst Stimulation (iTBS) triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 s to left dorsolateral prefrontal cortex. Total pulses = 14,400. To enable adherence and retention, the days do not need to be contiguous. Same day sessions will be separated by 10-15 minutes, but more accounting for participant comfort.