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

NCT05260190 | Unknown

• 1 other identifier: URJCtSMS100222
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Neurologic Disorder; Manual Dexterity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Hand grip strength

  5 minutes

Study Arms (2)

tSMS

EXPERIMENTAL

Real tSMS stimulation.

Device: tSMS

Sham tSMS

SHAM COMPARATOR

Sham tSMS stimulation.

Device: Sham tSMS

Interventions

tSMS DEVICE

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.

tSMS

Sham tSMS DEVICE

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.

Sham tSMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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...).

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Stroke; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 2, 2022
• Study Start: September 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: April 1, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)