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

NCT02763865 | Completed Results DMC

• 1 other identifier: Pro00033680
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Active pre-SMA rTMS

EXPERIMENTAL

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

Sham pre-SMA rTMS

SHAM COMPARATOR

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

Interventions

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.

Active pre-SMA rTMS

eSHAM system DEVICE

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

Sham pre-SMA rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Gonzalo REvuelta
• Organization: Medical University of South Carolina

revuelta@musc.edu

843-792-7262

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: May 5, 2016
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 21, 2017
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share