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

Primary Purpose

Essential Tremor

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil
eSHAM system
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Active pre-SMA rTMS

    Sham pre-SMA rTMS

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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)
    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)
    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)
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 12, 2016
    Last Updated
    February 8, 2019
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02763865
    Brief Title
    A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential Tremor
    Official Title
    A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    March 21, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Essential Tremor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active pre-SMA rTMS
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Sham pre-SMA rTMS
    Arm Type
    Sham Comparator
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    eSHAM system
    Intervention Description
    implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)
    Primary Outcome Measure Information:
    Title
    Mean TRS (Tremor Rating Score)
    Description
    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
    Title
    Mean TRS (Tremor Rating Score) at 4 Week Followup
    Description
    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
    4 week followup(visit 18)
    Title
    Mean TRS (Tremor Rating Score) at 8 Week Followup
    Description
    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
    8 week followup (visit 19)
    Title
    Mean TRS (Tremor Rating Score) at 12 Week Followup
    Description
    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
    12-week followup(visit 20)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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