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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260190
• Other study ID #: URJCtSMS100222
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2022
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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...).

Related Conditions & MeSH terms

• Manual Dexterity
• Nervous System Diseases
• Neurologic Disorder
• Stroke

Intervention

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 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.

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finger Tapping Test (FTT)	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.	5 minutes
Primary	Nine-Hole Peg Test (9HPT)	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.	5 minutes
Secondary	Hand grip strength	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.	5 minutes