Aftereffects and Reliability of Two Homeostatic Plasticity Induction Protocols

October 6, 2020 updated by: Priscilla G. Wittkopf, Aalborg University
People suffering from chronic pain exhibit changes in the way the central nervous system processes pain. Some of the changes in the central nervous system are associated with how the brain adapts to the process of different stimuli. There are several physiological mechanisms that regulates how the brain adapts to changes and one of these mechanisms is called homeostatic plasticity (or equilibrium plasticity ). In healthy participants homeostatic plasticity mechanisms have been tested and considered normal, whereas in patients with chronic conditions, such as low back pain, this mechanism was shown to be dysfunctional. However, it is unknown when this difference in the pain system develops. It is possible that homeostatic mechanism becomes impaired over a period of time. Current studies have investigate a cohort of patients and there is a lack of longitudinal designs. In order to investigate the long-term effects of pain on homeostatic plasticity mechanisms it is important to first investigate the reliability of the methods. This study will investigate the reliability of two protocols of homeostatic plasticity induction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to investigate the corticomotor excitability changes provoked by two homeostatic plasticity induction protocols, specifically the duration and the test-retest reliability of such corticomotor excitability changes.

A within-subject repeated-measures design will be used to evaluate the aftereffects and the reliability of two homeostatic plasticity induction protocols using cathodal transcranial direct current stimulation (tDCS) (experiment 1) and anodal tDCS (experiment 2). Each participant will take part in two experimental sessions during which homeostatic plasticity and corticomotor excitability will be induced and measured in the left primary motor cortex.

A sample size calculation was conducted using α of 0.05, β of 0.80 and effect size of 0.48 based on motor evoked potential (MEP) analysis of previous studies (Thapa, Schabrun, 2018, Thapa et al., 2018) resulting in a target of 13 participants. To account for differences in study designs and for the possibility of participant withdrawal/dropout, the investigators set target recruitment at 15 participants for each experiment.

Each participant will attend two identical experimental sessions on the same time in two consecutive days. During the experiment, participants will be seated comfortably with hands and arms at rest. First, the electromyography electrodes will be placed at the right hand muscle to be used for assessing the corticomotor excitability by recordings of motor evoked potentials by transcranial magnetic stimulation (TMS) on the left primary motor cortex. Then, the neoprene cap for tDCS on the left primary motor cortex will be mounted. The optimal scalp position (hot spot) for TMS stimulation will be identified and marked with a pen on the cap for standardisation. The corticomotor excitability in response to the homeostatic plasticity protocol (cathodal tDCS in experiment 1 or anodal tDCS in experiment 2) will be measured before and immediately post paradigm (time point 0-min), and then every 10 minutes for 70 minutes.

Homeostatic plasticity will be induced in the left primary motor cortex using tDCS applied for 7 minutes followed by an interval of 3 minutes and another block of 5 minutes of stimulation (Thapa, Schabrun, 2018, Thapa et al., 2018). A constant current of 1mA will be transmitted through the tDCS system (Starstim, Neuroelectrics, Barcelona, Spain), using two 3.14 cm2 Ag/AgCl gelled electrodes placed into holes of a neoprene cap corresponding to the international 10/10 EEG system, placed on participants head with the central Cz position aligned to the vertex of the head. In experiment 1 the cathode will be placed at C3 and return electrode placed at Fp2. In experiment 2 the anode will be placed at C3 and return electrode placed at Fp2.

Data distribution will be assessed using the Shapiro-Wilk test. A repeated measures analysis of variance (ANOVA) will be conducted on mean MEPs with factors Session (Day1 and Day2) and Time (baseline, 0 min, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min, 70 min). A Greenhouse-Geisser correction will be used if Mauchly's test shows that sphericity cannot be assumed. Adjustments will be made for multiple post-hoc comparisons using the Bonferroni correction. Results will be interpreted according to the level of statistical significance p≤0.05 and effect size reported as partial eta squared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9220
        • Aalborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, aged between 18-60 years, right-handed and can speak and understand English.

Exclusion Criteria:

  • Lack of ability to cooperate
  • History or present chronic pain or current acute pain
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Present and previous neurological disorders such as epilepsy, Alzheimer's disease, dementia, stroke, migraine and other headache disorders, multiple sclerosis, Parkinson's disease, neuroinfections, brain tumors and head trauma.
  • Present or previous musculoskeletal disorders such as tendonitis, degenerative disc disease, mechanical back syndrome, and ruptured/herniated disc.
  • Present or previous mental illnesses such as depression, bipolar disorder, and schizophrenia.
  • Current use of medications that may affect the trial (e.g. analgesics, anti-inflammatories, anti-depressives)
  • Contraindications to TMS application (history of epilepsy, metal implants in head or jaw, etc.)
  • Failure to pass the tDCS screening questionnaire
  • Failure to pass the "TASS questionnaire"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single arm
This is a within-subject repeated-measures design.
Other: Homeostatic plasticity induction using transcranial direct current stimulation
Homeostatic plasticity will be induced in the left primary motor cortex using tDCS applied for 7 minutes followed by an interval of 3 minutes and another block of 5 minutes of stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Motor evoked potentials change from baseline
Time Frame: 0 minutes post homeostatic plasticity induction
0 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time Frame: 10 minutes post homeostatic plasticity induction
10 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time Frame: 20 minutes post homeostatic plasticity induction
20 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time Frame: 30 minutes post homeostatic plasticity induction
30 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time Frame: 40 minutes post homeostatic plasticity induction
40 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time Frame: 50 minutes post homeostatic plasticity induction
50 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time Frame: 60 minutes post homeostatic plasticity induction
60 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time Frame: 70 minutes post homeostatic plasticity induction
70 minutes post homeostatic plasticity induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N-20190069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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