Manual Dexterity Modifications After Application of tSMS Over the Primary Motor Cortex (M1)

Sponsor

Universidad Rey Juan Carlos (Other)

Overall Status

Recruiting

CT.gov ID

NCT05260190

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Transcranial static magnetic field stimulation (tSMS) is a novel brain stimulation technique that has been shown to be safe and effective in modifying biological parameters when applied to the cerebral cortex. Its application decreases cortical excitability, regardless of the polarity of the magnetic field, reducing the amplitude of motor evoked potentials (MEP). tSMS is presented as a potentially useful tool in the management of the interhemispheric inhibition, a condition present in neurological pathologies such as stroke or multiple sclerosis. Despite having demonstrated neurophysiological effects in previous studies, the effects of tSMS application on force production and manual dexterity, have not yet been clearly established.

The present study aims to evaluate changes in force production, manual dexterity, and fatigue after unilateral application of a tSMS session on the primary motor cortex (M1). It is hypothesized that the application of tSMS will momentarily decrease the parameters of strength and manual dexterity in the upper limb contralateral to the stimulated cortex, without changes in the strength and dexterity of the unstimulated hemibody. These parameters may show an increase in the unstimulated hemibody. If the hypothesis is confirmed, it could be considered a valid treatment for health conditions presenting interhemispheric inhibition.

Condition or Disease	Intervention/Treatment	Phase
Stroke Neurologic Disorder Manual Dexterity	Device: tSMS Device: Sham tSMS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Several devices (helmets) were available for the active and sham intervention. An investigator outside the study intervention labeled the active and sham helmets with an alphabetic code (A or B). The investigator applying the stimulation did not know which type of intervention was applying (A or B). Neither the investigator performing the intervention, nor the participant knew which intervention corresponded to each group. The data were analyzed by another researcher who was not involved in the assignment and intervention.

Primary Purpose:

Health Services Research

Official Title:

Hand Grip Strength and Manual Dexterity Modifications After Application of Transcranial Static Magnetic Field Stimulation (tSMS) Over the Primary Motor Cortex (M1) in Healthy Subjects

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tSMS Real tSMS stimulation.	Device: tSMS 30-minute tSMS application in a comfortable seated position. The material used in the stimulation was a MAGxx1.1 helmet (Neurek Spain Toledo), with a Neodymium (NdFeB) magnet of 60mm diameter and 30mm height with Nickel (Ni-Cu-Ni) coating MAG60r+ (Neurek Spain, Toledo), placed over the primary motor cortex (M1) of the left cerebral hemisphere.
Sham Comparator: Sham tSMS Sham tSMS stimulation.	Device: Sham tSMS 30-minute sham tSMS application in a comfortable seated position. The device used in sham stimulation had the same weight and shape as the real stimulation helmet.

Arm

Intervention/Treatment

Experimental: tSMS

Real tSMS stimulation.

Device: tSMS

30-minute tSMS application in a comfortable seated position. The material used in the stimulation was a MAGxx1.1 helmet (Neurek Spain Toledo), with a Neodymium (NdFeB) magnet of 60mm diameter and 30mm height with Nickel (Ni-Cu-Ni) coating MAG60r+ (Neurek Spain, Toledo), placed over the primary motor cortex (M1) of the left cerebral hemisphere.

Sham Comparator: Sham tSMS

Sham tSMS stimulation.

Device: Sham tSMS

30-minute sham tSMS application in a comfortable seated position. The device used in sham stimulation had the same weight and shape as the real stimulation helmet.

Outcome Measures

Primary Outcome Measures

Finger Tapping Test (FTT) [5 minutes]
was performed for assessment of manual motor skills. This test has been used for many years in the neuropsychological assessment of brain damage, being an indicator of cortical activity, as well as being used in NIBS studies as a measure of manual dexterity.
Nine-Hole Peg Test (9HPT) [5 minutes]
Was used to assess finger dexterity; this tool has been used in the assessment of motor activity in a multitude of pathologies, with adequate to excellent inter-rater reliability and excellent inter-rater reliability in healthy adults.

Secondary Outcome Measures

Hand grip strength [5 minutes]
Upper extremity force production was assessed by grip testing; a hand-held dynamometer (Jamar Plus+; Sammons Preston, Rolyon, Bolingbrook, IL) was used for this purpose. Greater hand grip strength corresponds with greater activation in M1, premotor area (PMA), and supplementary motor area (SMA) in the dominant hemisphere, and of the SMA in the nondominant hemisphere, and may provide information about the functionality of the human brain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 18 and 60 years.
Absence of cognitive impairment.
Adequate understanding of verbal and written information, sufficient to complete the tests.

Exclusion Criteria:

Presence of metallic implants (e.g., neurostimulator, pacemaker, cochlear implant, or metallic elements in the head or around the eyes).
Diagnosis of epilepsy or being under treatment with antiepileptic drugs.
Diagnosis of unstable cardiovascular disease.
Diagnosis of any disease or condition that may interfere with this study.
Use of drugs that may influence with neuromuscular function (muscle relaxants or some analgesics...).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Rey Juan Carlos	Alcorcón	Madrid	Spain	28922

Sponsors and Collaborators

Universidad Rey Juan Carlos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Josue Fernandez Carnero, Principal Investigator, Universidad Rey Juan Carlos

ClinicalTrials.gov Identifier:

NCT05260190

Other Study ID Numbers:

URJCtSMS100222

First Posted:

Mar 2, 2022

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Nervous System Diseases

Study Results

No Results Posted as of Mar 2, 2022