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

Not Applicable

Completed

• Conditions: Essential Tremor
• Interventions: Device: MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil; Device: eSHAM system

• Registration Number: NCT02763865
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-12
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-05
• Study Completion: 2017-03-21
• Results First Submitted: 2018-07-13
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-08
• Last Update Submitted: 2019-02-08
• Results First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active pre-SMA rTMS	MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil	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).
Sham pre-SMA rTMS	eSHAM system	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).

Primary Outcome Measures

Name	Time	Method
Mean TRS (Tremor Rating Score)	Baseline (Visit 2) post intervention	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)
Mean TRS (Tremor Rating Score) at 4 Week Followup	4 week followup(visit 18)	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)
Mean TRS (Tremor Rating Score) at 12 Week Followup	12-week followup(visit 20)	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)
Mean TRS (Tremor Rating Score) at 8 Week Followup	8 week followup (visit 19)	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)