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

NCT ID: NCT02763865

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-03-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active pre-SMA rTMS

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Sham pre-SMA rTMS

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).

Group Type: SHAM_COMPARATOR

eSHAM system

Intervention Type: DEVICE

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

Interventions

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

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

eSHAM system

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Pro00033680

Identifier Type: -

Identifier Source: org_study_id