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tSMS in Essential Tremor

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ClinicalTrials.gov Identifier: NCT03780426
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Essential Tremor Device: tSMS Device: sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: tSMS left motor cortex (sham right)
30 min of tSMS applied to the left motor cortex with sham on the right motor cortex
Device: tSMS
Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability (Oliviero et al., 2011; Oliviero et al., 2015; Dileone et al., 2018). Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the left or right motor cortex, using a tSMS helmet (MAGmv1.0; Neurek SL, Toledo, Spain).
Other Name: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)

Device: sham
A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain) of motor cortex contralateral to the stimulated hemisphere.
Other Name: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)

Experimental: tSMS right motor cortex (sham left)
30 min of tSMS applied to the right motor cortex with sham on the left motor cortex
Device: tSMS
Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability (Oliviero et al., 2011; Oliviero et al., 2015; Dileone et al., 2018). Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the left or right motor cortex, using a tSMS helmet (MAGmv1.0; Neurek SL, Toledo, Spain).
Other Name: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)

Device: sham
A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain) of motor cortex contralateral to the stimulated hemisphere.
Other Name: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry. [ Time Frame: 15 minutes after treatment compared to baseline ]
  2. Change from baseline in rest tremor amplitude, as measured by accelerometry. [ Time Frame: Immediately after treatment and 15 minutes after treatment compared baseline. ]
  3. Change from baseline in tremor frequency, as measured by accelerometry. [ Time Frame: Immediately after treatment and 15 minutes after treatment compared baseline. ]
  4. Change from baseline in the Clinical Rating Scale for Tremor part B (drawing) [ Time Frame: 5 minutes after treatment and 20 minutes after treatment compared to baseline ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Essential tremor

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780426


Contacts
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Contact: Guglielmo Foffani, PhD guglielmo.foffani@gmail.com

Locations
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Spain
CINAC, Hospital Universitario Puerta del Sur Recruiting
Móstoles, Madrid, Spain, 28938
Contact: Guglielmo Foffani, PhD       guglielmo.foffani@gmail.com   
Sponsors and Collaborators
Fundación de investigación HM

Publications:
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Responsible Party: Fundación de investigación HM
ClinicalTrials.gov Identifier: NCT03780426     History of Changes
Other Study ID Numbers: Fundacion de Investigación HM
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases