tSMS in Essential Tremor

Phase 2

Completed

• Conditions: Essential Tremor

• Registration Number: NCT03780426
• Lead Sponsor: Fundación de investigación HM

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Essential tremor

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	Immediately after treatment compared baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CINAC, Hospital Universitario Puerta del Sur; 🇪🇸 Móstoles, Madrid, Spain