Muscle LossImmobiStimNCT04130581
Brain Stimulation During Arm Immobilisation
A study testing Transcranial Magnetic Stimulation (TMS) in people with Muscle Loss, run by Lancaster University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 May 2018to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- right-handed
- aged 18-30
- healthy BMI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lancaster University
Lancaster, Lancashire, LA1 4YF
About this study
Official title: 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.
- Conditions
- Muscle Loss
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 24, 48, and 72 hours
Secondary outcomes (1)
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.
Measured: 0, and 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start14 May 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Nuttall, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130581
- Sponsor's protocol ID
- PSA1775
- Acronym
- ImmobiStim
- Status last verified
- Feb 2020
- First submitted
- 15 Oct 2019
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercising the Motor Cortex Using Brain Stimulation
- ClinicalTrials.gov ID
- NCT04130581
- Acronym / sponsor ID
- ImmobiStim / PSA1775
- Conditions
- Muscle Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Other: Transcranial Magnetic Stimulation (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. |
| Sham | Sham comparator | Other: Transcranial Magnetic Stimulation (TMS)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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- right-handed
- aged 18-30
- healthy BMI
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Sham, TMS |
Primary outcome
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.
1 secondary outcome
Change in grip strength across time points
Time frame: 0, and 72 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Muscle Loss, run by Lancaster University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motor Evoked Potentials (MEPs) across time points (time frame: 0, 24, 48, and 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.