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

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763865
• Other study ID #: Pro00033680
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: March 21, 2017

Study information

• Verified date: February 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 21, 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• 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.
• eSHAM system
implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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)