Brain Stimulation During Arm Immobilisation (ImmobiStim)

Exercising the Motor Cortex Using Brain Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Muscle Loss
• Intervention / Treatment: Other: Transcranial Magnetic Stimulation (TMS)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lancashire
    • Lancaster, Lancashire, United Kingdom, LA1 4YF
      • Lancaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TMS; Six 30-pulse trains of 20 Hz repetitive Transcranial Magnetic Stimulation to left primary motor cortex hand area, separated by 60 seconds, repeated at 0, 24, 48, and 72 hours post-immobilisation.	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.
Sham Comparator: Sham; Six 30-pulse trains of 20 Hz repetitive sham Transcranial Magnetic Stimulation above, but not in contact with, the head, separated by 60 seconds, repeated at 0, 24, 48, and 72 hours post-immobilisation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Lancaster University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PSA1775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No