NCT05252247

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

January 19, 2022

Last Update Submit

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

EXPERIMENTAL

Participants will attend three sessions where two consist of immobilisation or exercise interventions.

Other: ImmobilisationOther: Exercise

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.

Conditions

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.

Conditions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 21177994BACKGROUND
  • Thapa 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: 29472134BACKGROUND
  • Thapa 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: 33635391BACKGROUND
  • Wittkopf 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

ImmobilizationExercise

Intervention Hierarchy (Ancestors)

Investigative TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: This is a within-subject repeated measures comparisons study with one baseline session and two interventional sessions.
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

Locations