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Completed

NCT Number: NCT04130581

Brain Stimulation During Arm Immobilisation

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.

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Key information

Conditions

Muscle Loss Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lancaster University

Lancaster, Lancashire, LA1 4YF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial magnetic stimulation (TMS)

Other

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.

Primary outcomes

  1. Change in Motor Evoked Potentials (MEPs) across time points

    Time frame: 0, 24, 48, and 72 hours

    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.

Secondary outcomes

  1. Change in grip strength across time points

    Time frame: 0, and 72 hours.

    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.

Sponsors and collaborators

Lead sponsor

Lancaster University

Other

Registry information

Official study title

Exercising the Motor Cortex Using Brain Stimulation

Acronym: ImmobiStim

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2019
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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