Brain Stimulation During Arm Immobilisation

NCT04130581 | Completed

• 1 other identifier: PSA1775
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in grip strength across time points

  0, and 72 hours.

Study Arms (2)

TMS

EXPERIMENTAL

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)

Sham

SHAM COMPARATOR

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)

Interventions

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.

Sham; TMS

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• right-handed
• aged 18-30
• healthy BMI

You may not qualify if:

• 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

Sponsors & Collaborators

• Lancaster University: lead

Study Sites (1)

Lancaster University

Lancaster, Lancashire, LA1 4YF, United Kingdom

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Cognitive Neuroscience

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: May 14, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)