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

Medical University of South Carolina10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Essential Tremor

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Greater than 18 of age * Meet the diagnostic criteria for essential tremor with visible upper limb tremor * Must be either on stable medications to treat tremor for 30 days, or no medications to treat tremor Exclusion Criteria: * History of seizures * History of chronic pain conditions * Any metal in their body above their shoulders * Use of medications that lower seizure threshold including: * broad classes of drugs such as tricyclic antidepressants * anti-psychotics * neuroeptics * thyroid medications and stimulants * Use of any medications that cause tremor, Pregnancy

Outcomes

Primary Outcomes

Mean TRS (Tremor Rating Score)

Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)

Time frame: Baseline (Visit 2) post intervention

Mean TRS (Tremor Rating Score) at 4 Week Followup

Time frame: 4 week followup(visit 18)

Mean TRS (Tremor Rating Score) at 8 Week Followup

Time frame: 8 week followup (visit 19)

Mean TRS (Tremor Rating Score) at 12 Week Followup

Time frame: 12-week followup(visit 20)