At a glance

ClinicalIndex Comparison Record

N/ACompleted· 10 enrolled

Drug / intervention

MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil +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/NCT02763865

NCT02763865N/ACompleted

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A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential

Medical University of South Carolina·interventional·Posted May 5, 2016·Updated Feb 15, 2019

In Brief

A clinical study evaluating MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil and eSHAM system for Essential Tremor. Completed, enrolled 10 participants.

Detailed Summary

The purpose of this study is to determine the effects of Low Frequency Repetitive Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET). Hypothesis: Pre-SMA LF r-TMS will result in a \>30% reduction in tremor as measured by the TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the pre-SMA effects tremor in patients with ET. Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing pre-SMA output, and improving motor control, as determined shortening of the delay in the second agonist burst, seen in ET patients. At conclusion of this study expect to have sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of pre-SMA r-TMS in ET.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEssential Tremor

Countries--

Collaborators--

Timeline

N/ACompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartJul 2014

Primary CompletionDec 2015

First PostedMay 2016

Study CompletionMar 2017

TodayJul 2026

First PostedMay 5, 2016

Enrollment StartJul 1, 2014

Primary CompletionDec 1, 2015

Study CompletionMar 21, 2017

TodayJul 2, 2026

Enrollment to primary: 1.4 yearsPosted 10.2 years ago

Interventions

MagVenture MagProx100 Stimulator with a Cool-B65 A/P coildevice

Active rTMS administration (1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total. Resting motor threshold assessment the TMS machine will initially be set to 50% of its maximal output.

eSHAM systemdevice

implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)