The Effects of Immobilisation and Exercise on Homeostatic Plasticity Mechanisms in Healthy Participants
1 other identifier
interventional
11
1 country
1
Brief Summary
Homeostasis is important for maintaining a stable equilibrium of e.g., blood pressure, hormonal release, and release of neurotransmitters. Within the healthy brain, homeostatic plasticity mechanisms ensure stability in synaptic plasticity that maintains cortical excitability within a normal physiological range, while this regulation has been shown to be impaired in chronic pain conditions such as low back pain. Cortical excitability can also be decreased and increased experimentally, using immobilisation and exercise paradigms, respectively, yet it is unknown if this overall change in excitability is caused by a shift in homeostatic plasticity regulation. Investigating if immobilisation and exercise influences homeostatic plasticity responses, may therefore reveal important information on the malleability of homeostatic plasticity mechanisms and ways to modulate them.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2022
CompletedStudy Start
First participant enrolled
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 6, 2023
February 1, 2023
11 months
January 19, 2022
February 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Corticospinal excitability
Change in corticospinal excitability (compared to baseline), as reflected by motor-evoked potential amplitudes induced by transcranial magnetic stimulation, after homeostatic plasticity induction
Immediately after [0 minutes after homeostatic plasticity induction] and every 10 minutes up until 30 minutes after [10-30 minutes after homeostatic plasticity induction]
Secondary Outcomes (12)
Quantitative Sensory Testing: Cuff detection threshold
Before and 30 minutes post homeostatic plasticity induction
Quantitative Sensory Testing: Cuff pain tolerance threshold
Before and 30 minutes post homeostatic plasticity induction
Quantitative Sensory Testing: Conditioned pain modulation
Before and 30 minutes post homeostatic plasticity induction
Quantitative Sensory Testing: Temporal summation of pain
Before and 30 minutes post homeostatic plasticity induction
Quantitative Sensory Testing: Mechanical pain threshold
Before and 30 minutes post homeostatic plasticity induction
- +7 more secondary outcomes
Study Arms (1)
Conditions
EXPERIMENTALParticipants will attend three sessions where two consist of immobilisation or exercise interventions.
Interventions
Eight hours prior to attending the immobilisation session, a splint will be fitted to the hand of the participant and remain until the session start.
Eight hours prior to attending the exercise session, the participant will be instructed to perform 150 ballistic finger movements every hour until the session start.
Eligibility Criteria
You may qualify if:
- o Healthy, aged between 18-60 years, right-handed, and can speak, read, and understand Danish or English
You may not qualify if:
- Pregnant or breastfeeding
- Regular use of cannabis, opioids or other drugs (except contraceptives)
- Current or previous neurologic, musculoskeletal, mental, or other illnesses (e.g. brain or spinal cord injuries, degenerative neurological disorders, epilepsy, major depression, cardiovascular disease, chronic lung disease, etc.)
- Current or previous chronic or recurrent pain condition
- Current regular use of analgesic medication or other medication which may affect the trial (including paracetamol and NSAIDs)
- Lack of ability to cooperate
- Recent history of acute pain particularly in the lower limbs (unless related to low back pain in patients included in sub-project 6)
- Abnormally disrupted sleep in 24 hours preceding experiment
- Any medical or other condition (i.e. musculoskeletal, cardiorespiratory, neurological, etc.)
- Contraindications to TMS application (history of epilepsy, metal implants in head or jaw, etc.)
- Unable to pass the "Transcranial Magnetic Stimulation Adult Safety Screen" or tDCS screening questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aalborg University
Aalborg, North Denmark, 9220, Denmark
Related Publications (4)
Fricke K, Seeber AA, Thirugnanasambandam N, Paulus W, Nitsche MA, Rothwell JC. Time course of the induction of homeostatic plasticity generated by repeated transcranial direct current stimulation of the human motor cortex. J Neurophysiol. 2011 Mar;105(3):1141-9. doi: 10.1152/jn.00608.2009. Epub 2010 Dec 22.
PMID: 21177994BACKGROUNDThapa T, Graven-Nielsen T, Chipchase LS, Schabrun SM. Disruption of cortical synaptic homeostasis in individuals with chronic low back pain. Clin Neurophysiol. 2018 May;129(5):1090-1096. doi: 10.1016/j.clinph.2018.01.060. Epub 2018 Feb 9.
PMID: 29472134BACKGROUNDThapa T, Graven-Nielsen T, Schabrun SM. Aberrant plasticity in musculoskeletal pain: a failure of homeostatic control? Exp Brain Res. 2021 Apr;239(4):1317-1326. doi: 10.1007/s00221-021-06062-3. Epub 2021 Feb 26.
PMID: 33635391BACKGROUNDWittkopf PG, Larsen DB, Gregoret L, Graven-Nielsen T. Prolonged corticomotor homeostatic plasticity - Effects of different protocols and their reliability. Brain Stimul. 2021 Mar-Apr;14(2):327-329. doi: 10.1016/j.brs.2021.01.017. Epub 2021 Jan 24. No abstract available.
PMID: 33503491BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 19, 2022
First Posted
February 23, 2022
Study Start
February 15, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
February 6, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share