HealthyNCT04324801
Aftereffects and Reliability of Two Homeostatic Plasticity Induction Protocols
A study testing Homeostatic plasticity induction using transcranial direct current stimulation in people with Healthy, run by Aalborg University at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Homeostatic plasticity induction using transcranial direct current stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2020to 9 Jun 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, aged between 18-60 years, right-handed and can speak and understand English.
Who cannot join
- 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.
Show all 11Show fewer
- 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"
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Homeostatic plasticity induction using transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeostatic plasticity induction using transcranial direct current stimulationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | This is a within-subject repeated-measures design. Receives: Other: Homeostatic plasticity induction using transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potentials change from baseline
Measured: 0 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Measured: 10 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Measured: 20 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Measured: 30 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Measured: 40 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Measured: 50 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Measured: 60 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Measured: 70 minutes post homeostatic plasticity induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start15 Jan 2020
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscilla G. Wittkopf, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324801
- Sponsor's protocol ID
- N-20190069
- Status last verified
- Oct 2020
- First submitted
- 25 Mar 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29472134Thapa T, Schabrun SM. Test-Retest Reliability of Homeostatic Plasticity in the Human Primary Motor Cortex. Neural Plast. 2018 Jun 10;2018:6207508. doi: 10.1155/2018/6207508. eCollection 2018.
PubMed 29983706Karabanov A, Ziemann U, Hamada M, George MS, Quartarone A, Classen J, Massimini M, Rothwell J, Siebner HR. Consensus Paper: Probing Homeostatic Plasticity of Human Cortex With Non-invasive Transcranial Brain Stimulation. Brain Stimul. 2015 May-Jun;8(3):442-54. doi: 10.1016/j.brs.2015.01.404. Epub 2015 Apr 1.
PubMed 26050599Fricke 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.
PubMed 21177994Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
PubMed 25797650
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aftereffects and Reliability of Two Homeostatic Plasticity Induction Protocols
- ClinicalTrials.gov ID
- NCT04324801
- Acronym / sponsor ID
- N-20190069
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 27 Mar 2020 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: Homeostatic plasticity induction using transcranial direct current stimulationThis is a within-subject repeated-measures design. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, aged between 18-60 years, right-handed and can speak and understand English.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Homeostatic plasticity induction using transcranial direct current stimulationHomeostatic 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 | Other | Single arm |
Primary outcome
Motor evoked potentials change from baseline
Time frame: 0 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time frame: 10 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time frame: 20 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time frame: 30 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time frame: 40 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time frame: 50 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time frame: 60 minutes post homeostatic plasticity induction
Motor evoked potentials change from baseline
Time frame: 70 minutes post homeostatic plasticity induction
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 8 Oct 2020.
- Background: PubMed 29472134Thapa 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.
- Background: PubMed 29983706Thapa T, Schabrun SM. Test-Retest Reliability of Homeostatic Plasticity in the Human Primary Motor Cortex. Neural Plast. 2018 Jun 10;2018:6207508. doi: 10.1155/2018/6207508. eCollection 2018.
- Background: PubMed 26050599Karabanov A, Ziemann U, Hamada M, George MS, Quartarone A, Classen J, Massimini M, Rothwell J, Siebner HR. Consensus Paper: Probing Homeostatic Plasticity of Human Cortex With Non-invasive Transcranial Brain Stimulation. Brain Stimul. 2015 May-Jun;8(3):442-54. doi: 10.1016/j.brs.2015.01.404. Epub 2015 Apr 1.
- Background: PubMed 21177994Fricke 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.
- Background: PubMed 25797650Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
- 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 Homeostatic plasticity induction using transcranial direct current stimulation in people with Healthy, run by Aalborg University at 1 site in Denmark.
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 1 inclusion and 11 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 8 Oct 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 Denmark. 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. 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?
Motor evoked potentials change from baseline (time frame: 0 minutes post homeostatic plasticity induction). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324801, which also lists 5 linked publications.
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 8 Oct 2020.