跳至主要内容
临床试验/NCT05252247
NCT05252247已完成不适用

The Effects of Immobilisation and Exercise on Homeostatic Plasticity Mechanisms in Healthy Participants

Aalborg University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2022年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
Corticospinal excitability

研究概览

简要总结

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.

详细描述

The aim of this study is to investigate the impact of upper limb immobilisation and physical exercise of the hand on homeostatic plasticity in healthy individuals.

The study will be performed as a randomised cross-over study where each participant take part in three sessions, separated by approximately 24 hours. During each session, the participant will answer questionnaires and undergo quantitative sensory testing (QST). Baseline measures is obtained using transcranial magnetic stimulation (TMS)-induced motor evoked potentials (MEPs), which is done before the induction of homeostatic plasticity using transcranial direct current stimulation (tDCS). MEPs are then obtained every 10 minutes for 30 minutes. Lastly, QST measures are obtained again.

As no previous studies have investigated the effect of immobilisation and exercise on homeostatic plasticity response, a sample size calculation was estimated based on MEP analysis from a previous study using α of 0.05, β of 0.80, and effect size of 0.29, yielding 22 participants. This is consistent with recent exploratory research that suggested that up to 28 participants would be needed. Therefore, the current study aimed at including 28 participants with an interim analysis performed after 10-15 inclusions.

Each participant will attend three identical experimental sessions on the same time on three consecutive days. Eight hours before attending the experimental sessions with immobilisation the participant will be fitted a splint (MANU-Hit DIGITUS POLLEX, Clinical Innovations, DK) to immobilise the right hand. Similarly, eight hours before attending the exercise session, the participant will be instructed to perform 150 ballistic finger movements with a pace of 0.5 Hz. During the experiment, the participant will be seated comfortably with arms and hands at rest. Electromyography electrodes will be placed on the right first interosseous muscle to assess the corticomotor excitability by recording of TMS induced MEPs on the left primary motor cortex. A neoprene cap will then be mounted to the head, and the optimal site for TMS (hotspot) will be identified and marked on the cap for standardisation. The cortical excitability will be measured before and immediately after homeostatic plasticity induction (time point 0-min), and then every 10 minutes for 30 minutes.

Homeostatic plasticity will be induced using tDCS applied to the left primary motor cortex for 7 minutes, followed by a break of 3 minutes and another 5 minutes of tDCS. A constant current of 1mA will be transmitted through the tDCS system (Starstim 32, Neuroelectrics, Barcelona, Spain) using two gelled electrodes placed into holes of a neoprene cap at the position of C3 and Fp2.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •o Healthy, aged between 18-60 years, right-handed, and can speak, read, and understand Danish or English

排除标准

  • •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

研究组 & 干预措施

Conditions

Experimental

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

干预措施: Immobilisation (Other)

Conditions

Experimental

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

干预措施: Exercise (Other)

结局指标

主要结局

Corticospinal excitability

时间窗: Immediately after [0 minutes after homeostatic plasticity induction] and every 10 minutes up until 30 minutes after [10-30 minutes after homeostatic plasticity induction]

Change in corticospinal excitability (compared to baseline), as reflected by motor-evoked potential amplitudes induced by transcranial magnetic stimulation, after homeostatic plasticity induction

次要结局

  • Quantitative Sensory Testing: Temporal summation of pain(Before and 30 minutes post homeostatic plasticity induction)
  • Quantitative Sensory Testing: Handheld algometry at left dorsal interosseous muscle(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: Mechanical pain threshold(Before and 30 minutes post homeostatic plasticity induction)
  • Quantitative Sensory Testing: Handheld algometry at right dorsal interosseous muscle(Before and 30 minutes post homeostatic plasticity induction)
  • Questionnaires: Positive and Negative Affective Schedule(Before baseline corticospinal excitability measurements)
  • Quantitative Sensory Testing: Cuff pain tolerance threshold(Before and 30 minutes post homeostatic plasticity induction)
  • Quantitative Sensory Testing: Handheld algometry at right tibialis anterior muscle(Before and 30 minutes post homeostatic plasticity induction)
  • Questionnaires: Pain Catastrophizing Scale(Before baseline corticospinal excitability measurements)
  • Quantitative Sensory Testing: Cuff detection threshold(Before and 30 minutes post homeostatic plasticity induction)
  • Questionnaires: Pittsburgh Sleep Quality Index(Before baseline corticospinal excitability measurements)
  • Questionnaires: International Physical Activity Questionnaire(Before baseline corticospinal excitability measurements)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis Boye Larsen

Assistant Professor

Aalborg University

研究点 (1)

Loading locations...

相似试验