NCT02763865

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil	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.
DEVICE	eSHAM system	implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-12-01
• Completion: 2017-03-21
• First posted: 2016-05-05
• Last updated: 2019-02-15
• Results posted: 2019-02-15