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Completed

NCT Number: NCT02763865

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

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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 system

Device

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

Primary outcomes

  1. Mean TRS (Tremor Rating Score)

    Time frame: 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)

  2. Mean TRS (Tremor Rating Score) at 4 Week Followup

    Time frame: 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)

  3. Mean TRS (Tremor Rating Score) at 8 Week Followup

    Time frame: 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)

  4. Mean TRS (Tremor Rating Score) at 12 Week Followup

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
May 5, 2016
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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