Acute PainNCT04165876
HD-tDCS: Effects on the Somatosensory System
A study testing Primary Motor Cortex Stimulation, Dorsolateral Prefrontal Cortex Stimulation and Multimodal Stimulation (DLPFC+M1) in people with Acute Pain and Neuroplasticity, run by Aalborg University at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the efficacy of high definition tDCS on different cortical targets in modulating the nociceptive system in the healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Neuroplasticity, Brain Modulation
- What is being tested?
- Primary Motor Cortex Stimulation, Dorsolateral Prefrontal Cortex Stimulation and Multimodal Stimulation (DLPFC+M1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Dec 2018to 18 Mar 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 men and women.
- Able to speak, read and understand English or Danish.
Who cannot join
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Current use of opioids, antipsychotics, benzodiazepines
- Previous or current neurological, musculoskeletal, rheumatic, malignant, inflammatory or mental illnesses
- Current or prior chronic pain conditions
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Neuroplasticity and Pain
Aalborg, North Denmark, 9000
About this study
Official title: High Definition Transcranial Direct Current Stimulation: Effects on the Somatosensory System
The purpose of this study is to investigate the efficacy of high definition tDCS on different cortical targets in modulating the nociceptive system in the healthy subjects.
Read the detailed description
The investigators aim to investigate the efficacy of different HD-tDCS electrode configurations on modulating the somatosensory/nociceptive system.
This is done to investigate the hypothesis, that different stimulation protocols can be used to modulate the somatosensory and nociceptive system, as shown in the previous studies, but that it is necessary to uncover the most efficient way to do so.
The study uses a double-blinded, sham-controlled, longitudinal design, where quantitative sensory testing will be used to assess the somatosensory function of the participants before and after a receiving a specific configuration of HD-tDCS on three consecutive days.
- Conditions
- Acute Pain, Neuroplasticity, Brain Modulation, Somatosensory Function
- Being tested
- Primary Motor Cortex Stimulation, Dorsolateral Prefrontal Cortex Stimulation, Multimodal Stimulation (DLPFC+M1), Sham stimulation
- Keywords
- tDCS, HD-tDCS, Somatosensory function, QST, quantitative sensory testing, Non-invasive brain stimulation, NIBS, Transcranial Direct Current Stimulation
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Motor Cortex StimulationDevice
Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of primary motor cortex (M1) using a ring-cathode configuration
Dorsolateral Prefrontal Cortex StimulationDevice
Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of dorsolateral prefrontal cortex (DLPFC) using a ring-cathode configuration
Multimodal Stimulation (DLPFC+M1)Device
Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal multimodal stimulation of dorsolateral prefrontal cortex (DLPFC) and primary motor cortex simultaneously using ring-cathode configurations around the two anodes.
Sham stimulationDevice
Using the Starstim 32, HD-tDCS equipment we provide sham stimulation with 30 seconds of ramping up to 2 mA intensity, then turning off for 19 minutes and then ramping down from 2 mA intensity to 0 in the last 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Primary motor cortex | Active comparator | Not described Receives: Device: Primary Motor Cortex Stimulation |
| Dorsolateral prefrontal cortex | Active comparator | Not described Receives: Device: Dorsolateral Prefrontal Cortex Stimulation |
| Multi-modal stimulation (DLPFC+M1) | Active comparator | Not described Receives: Device: Multimodal Stimulation (DLPFC+M1) |
| Sham-stimulation | Sham comparator | Not described Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pressure pain threshold
A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe will be used to record the pressure pain threshold. The pressure is increased gradually at a rate of 30 kPa/s. The measurement is repeated three times on on flexor carpi radialis.
Measured: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the pain thresholds are assessed before and after each intervention on the subsequent two days.
Secondary outcomes (7)
Change in tactile detection threshold
Tactile threshold will be measured using an anaesthesiometer consisting of a set of Von Frey filaments. The filaments are made of nylon fibre of various diameters so as to provide a range of forces of up to 300 grams. The minimum force that the subject can detect will be identified. This will be assessed on flexor carpi radialis on the right hand arm.
Measured: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in mechanical pain threshold
Mechanical pain threshold (MPT) will be measured using a set of weighted pinprick stimulators with a flat contact area of 0.25 mm diameter that exert forces between 8 and 512 mN. Threshold procedures will use a method of limits with up to five series of ascending and descending stimulus intensities. This will be assessed on flexor carpi radialis on the right hand arm.
Measured: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in Thermal Sensory Detection
A 3×3 cm (9 cm2) contact thermode (Medoc Advanced Medical Systems, Israel) will be used to apply thermal stimulation. Each stimulus will be started at 32°C and thresholds of heat and cold sensory detection will be assessed by ascending or descending ramps in temperature to the cutoffs of 0-50 °C. This will be assessed on flexor carpi radialis on the right hand arm.
Measured: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in Thermal Pain Detection
A 3×3 cm (9 cm2) contact thermode (Medoc Advanced Medical Systems, Israel) will be used to apply thermal stimulation. Each stimulus will be started at 32°C and thresholds of heat and cold pain detection will be assessed by ascending or descending ramps in temperature to the cutoffs of 0-50 °C. This will be assessed on flexor carpi radialis on the right hand arm.
Measured: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in conditioned pain modulation (CPM)
A computer-controlled cuff pressure algometer (Nocitech, Denmark) with an air-filled tourniquet cuff (VBM, Germany) will be used to record cuff pressure-induced pain thresholds over the muscle bulk on the calfs. The pressure is increased gradually at a rate of 1 kPa/s to assess pain tolerance on a 0-10 VAS scale, where 0 is no pain at all and 10 is the worst pain imaginable.
During CPM testing, the pain tolerance is first assessed on one leg marking the baseline. The pressure pain tolerance is then assessed on the same leg again, while the contralateral calf is applied a simultaneous painful pressure stimulus. The outcome of the CPM testing is the difference in pressure pain tolerance measured in kPA between the first and the second assessment. The larger the positive difference is between the baseline and the second assessment, the stronger CPM effect the subject has.
Measured: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in vibration detection threshold.
Vibration detection threshold (VDT) will be determined with a Rydel-Seiffer tuning fork (64 Hz, 8/8 scale), which will be placed three times over a bony prominence of the distal part of the ulna on the right arm. Subjects are to indicate the disappearance of vibratory sensations.
Measured: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in temporal summation of pain (TSP).
TSP will be applied using cuff pressure algometry. A total of 10 repeated mechanical pressure stimuli will be delivered at 0.5 Hz (1-s stimuli duration and 1-s interval between stimuli) to the test area. During the 10 repeated stimuli, subjects will continuously rate the pain intensity on a 10-cm continuous VAS. TSP is assessed on the calf of the right leg.
Measured: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start18 Dec 2018
- Primary completion18 Feb 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal, sham-controlled, parallel groups design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Danish National Research Foundation
- Responsible party
- Principal investigator, Sebastian Kold Sørensen, Aalborg University
- Investigators
- Thomas Graven-Nielsen, Prof., Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165876
- Sponsor's protocol ID
- N-20180085.v1
- Status last verified
- Jun 2020
- First submitted
- 11 Sep 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kold S, Graven-Nielsen T. Effect of anodal high-definition transcranial direct current stimulation on the pain sensitivity in a healthy population: a double-blind, sham-controlled study. Pain. 2021 Jun 1;162(6):1659-1668. doi: 10.1097/j.pain.0000000000002187.
PubMed 33449508
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Transcranial Direct Current Stimulation: Effects on the Somatosensory System
- ClinicalTrials.gov ID
- NCT04165876
- Acronym / sponsor ID
- N-20180085.v1
- Conditions
- Acute Pain, Neuroplasticity, Brain Modulation, Somatosensory Function
- Keywords
- tDCS, HD-tDCS, Somatosensory function, QST, quantitative sensory testing, Non-invasive brain stimulation, NIBS, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Danish National Research Foundation
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 18 Nov 2019 (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.
The purpose of this study is to investigate the efficacy of high definition tDCS on different cortical targets in modulating the nociceptive system in the healthy subjects.
Detailed description
The investigators aim to investigate the efficacy of different HD-tDCS electrode configurations on modulating the somatosensory/nociceptive system.
This is done to investigate the hypothesis, that different stimulation protocols can be used to modulate the somatosensory and nociceptive system, as shown in the previous studies, but that it is necessary to uncover the most efficient way to do so.
The study uses a double-blinded, sham-controlled, longitudinal design, where quantitative sensory testing will be used to assess the somatosensory function of the participants before and after a receiving a specific configuration of HD-tDCS on three consecutive days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Longitudinal, sham-controlled, parallel groups design.
| Arm | Type | Receives |
|---|---|---|
| Primary motor cortex | Active comparator | Device: Primary Motor Cortex Stimulation |
| Dorsolateral prefrontal cortex | Active comparator | Device: Dorsolateral Prefrontal Cortex Stimulation |
| Multi-modal stimulation (DLPFC+M1) | Active comparator | Device: Multimodal Stimulation (DLPFC+M1) |
| Sham-stimulation | Sham comparator | Device: Sham stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women.
- Able to speak, read and understand English or Danish.
Key exclusion criteria (6 listed)
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Current use of opioids, antipsychotics, benzodiazepines
- Previous or current neurological, musculoskeletal, rheumatic, malignant, inflammatory or mental illnesses
- Current or prior chronic pain conditions
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 |
|---|---|---|
| Primary Motor Cortex StimulationUsing the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of primary motor cortex (M1) using a ring-cathode configuration | Device | Primary motor cortex |
| Dorsolateral Prefrontal Cortex StimulationUsing the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of dorsolateral prefrontal cortex (DLPFC) using a ring-cathode configuration | Device | Dorsolateral prefrontal cortex |
| Multimodal Stimulation (DLPFC+M1)Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal multimodal stimulation of dorsolateral prefrontal cortex (DLPFC) and primary motor cortex simultaneously using ring-cathode configurations around the two anodes. | Device | Multi-modal stimulation (DLPFC+M1) |
| Sham stimulationUsing the Starstim 32, HD-tDCS equipment we provide sham stimulation with 30 seconds of ramping up to 2 mA intensity, then turning off for 19 minutes and then ramping down from 2 mA intensity to 0 in the last 30 seconds. | Device | Sham-stimulation |
Primary outcome
Change in pressure pain threshold
Time frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the pain thresholds are assessed before and after each intervention on the subsequent two days.
A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe will be used to record the pressure pain threshold. The pressure is increased gradually at a rate of 30 kPa/s. The measurement is repeated three times on on flexor carpi radialis.
7 secondary outcomes
Change in tactile detection threshold
Time frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in mechanical pain threshold
Time frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in Thermal Sensory Detection
Time frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in Thermal Pain Detection
Time frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in conditioned pain modulation (CPM)
Time frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in vibration detection threshold.
Time frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
Change in temporal summation of pain (TSP).
Time frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.
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 11 Jun 2020.
- Derived from this study: PubMed 33449508Kold S, Graven-Nielsen T. Effect of anodal high-definition transcranial direct current stimulation on the pain sensitivity in a healthy population: a double-blind, sham-controlled study. Pain. 2021 Jun 1;162(6):1659-1668. doi: 10.1097/j.pain.0000000000002187.
- Individual participant dataSharing planned: No
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
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.
Thomas Graven-Nielsen, Prof. principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Motor Cortex Stimulation, Dorsolateral Prefrontal Cortex Stimulation and Multimodal Stimulation (DLPFC+M1) in people with Acute Pain and Neuroplasticity, 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 2 inclusion and 6 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 11 Jun 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. Some participants in this study may receive a placebo. 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?
Change in pressure pain threshold (time frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the pain thresholds are assessed before and after each intervention on the subsequent two days.). 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 NCT04165876, which also lists 1 linked publication.
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 11 Jun 2020.