N/A
N=10
A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential Tremor
Essential Tremor
Bottom Line
View on ClinicalTrials.gov: NCT02763865 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Mean TRS (Tremor Rating Score) — 26.6; 27.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil (Device); eSHAM system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean TRS (Tremor Rating Score) |
26.6; 27.6 | — |
| PRIMARY Mean TRS (Tremor Rating Score) at 4 Week Followup |
29.60; 29.2 | — |
| PRIMARY Mean TRS (Tremor Rating Score) at 8 Week Followup |
29.6; 29.6 | — |
| PRIMARY Mean TRS (Tremor Rating Score) at 12 Week Followup |
32.8; 29.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02763865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.