Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor

Fundación de investigación HM1 site in 1 country30 target enrollmentOctober 1, 2018

ConditionsEssential Tremor

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Essential Tremor
Sponsor: Fundación de investigación HM
Enrollment: 30
Locations: 1
Primary Endpoint: Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is randomized double-blind study to study the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex improves tremor in patients with essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other half of the right hemisphere.

Registry

clinicaltrials.gov

Start Date

October 1, 2018

End Date

December 1, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fundación de investigación HM

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Essential tremor

Exclusion Criteria

•MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
•other main neuropsychiatric co-morbidity
•pregnancy

Outcomes

Primary Outcomes

Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry.

Time Frame: Immediately after treatment compared baseline

Secondary Outcomes

Change from baseline in tremor frequency, as measured by accelerometry.(Immediately after treatment and 15 minutes after treatment compared baseline.)
Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.(15 minutes after treatment compared to baseline)
Change from baseline in rest tremor amplitude, as measured by accelerometry.(Immediately after treatment and 15 minutes after treatment compared baseline.)
Change from baseline in the Clinical Rating Scale for Tremor part B (drawing)(5 minutes after treatment and 20 minutes after treatment compared to baseline)