Brain Stimulation During Arm Immobilisation

Muscle Loss Clinical Trial

— ImmobiStim  

Official title:

Exercising the Motor Cortex Using Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130581
• Other study ID #: PSA1775
• Status: Completed
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: Lancaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research project explores how non-invasive brain stimulation can be used to detect and ameliorate loss of muscle strength after inactivity. At present, there is a limited understanding of how to maintain muscle strength during inactivity. Increasing evidence indicates that reduction in muscle strength following immobilisation is associated with reduced cortical motor output. Therefore, the aim of the study is to test if brain stimulation, can maintain cortical motor output and ameliorate the loss of muscle strength following immobilisation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Male

• right-handed

• aged 18-30

• healthy BMI

Exclusion Criteria:

• no primary muscle disorders

• no open wounds or skin conditions to arms and hands

• no neurological disorders or history of

• no history of fainting/convulsions

• no metal implanted into head/eye/neck

• non-smoker

• no arm, hand, fingers, shoulder injuries

Related Conditions & MeSH terms

• Muscle Loss

Intervention

Other:
• Transcranial Magnetic Stimulation (TMS)
TMS is a safe and non-invasive technique, which involves the generation of brief magnetic pulses applied to the head through a coil. The magnetic pulses pass through the scalp and skull and induce weak electric currents in the neural tissue directly underneath the coil. When TMS is applied in repetitive, patterned trains of pulses (rTMS), it can induce cortical plasticity specifically in the targeted brain region.

Locations

Country	Name	City	State
United Kingdom	Lancaster University	Lancaster	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Lancaster University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Motor Evoked Potentials (MEPs) across time points	MEPs are elicited via TMS to primary motor cortex and index the excitability of the motor pathway. They are recorded non-invasively from muscles using surface electrodes. At each time point of the study (0, 24, 48, 72 hours) record MEPs will be recorded pre and post-intervention from the hand muscles of the dominant (immobilised) arm, and non-dominant (non-immobilised arm), to evaluate changes in excitability. Specifically, the peak-to-peak value of the MEPs from the hand will be measured, which reflects the amplitude of the MEP response. The latency of the MEP to index neural conduction speed will also be measured.	0, 24, 48, and 72 hours
Secondary	Change in grip strength across time points	Grip strength of the dominant and non-dominant hands will be assessed using an isokinetic dynamometer at 0 and 72 hrs post-immobilisation. This will measure the strength of the hand muscles.	0, and 72 hours.