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

Study Overview
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Brief Summary
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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.

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

Conditions
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Essential Tremor

Intervention / Treatment
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* Device: MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil
* Device: eSHAM system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active pre-SMA rTMS<br>The intervention to be administered is the MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil l to administer active rTMS at 1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total. Two Thymapad Stimulus Electrodes will be placed in the appropriate position during active rTMS administration.This intervention method will be used for all 15 treatment sessions (20 minutes/session). | Device: MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil<br>* 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.<br>|
| Sham Comparator: Sham pre-SMA rTMS<br>The intervention to be administered is the eSHAM system used in conjunction with the MagVenture MagProx100 Stimulator with the Cool-B65 A/P Coil. For eSHAM administration two Thymapad Stimulus Electrodes will be placed on the scalp location that corresponded to left DLPFC. This intervention method will be used for all 15 treatment sessions (20 minutes/session). Previous studies have shown the eSHAM system effectively blinds participants to rTMS treatment (active versus sham). | Device: eSHAM system<br>* implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline (Visit 2) post intervention | 
| Mean TRS (Tremor Rating Score) at 4 Week Followup | 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) | 4 week followup(visit 18) | 
| Mean TRS (Tremor Rating Score) at 8 Week Followup | 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) | 8 week followup (visit 19) | 
| Mean TRS (Tremor Rating Score) at 12 Week Followup | 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) | 12-week followup(visit 20) |