HealthyNCT04658485
The Effect of Transcranial Direct Current Stimulation of the Primary Motor and Somatosensory Cortex on Pain Thresholds.
A study testing Active tDCS in people with Healthy, run by Aalborg University at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the modulatory effect of a novel tDCS configuration on the pain sensitivity in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2019to 15 Feb 2021
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Age between 18-30 years
- Living in Denmark
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: The Modulatory Effect of Anodal Primary Motor Cortex and Cathodal Primary Somatosensory Cortex Transcranial Direct Current Stimulation on Pain Thresholds in the Neck Musculature.
The purpose of this study is to investigate the modulatory effect of a novel tDCS configuration on the pain sensitivity in healthy subjects.
Read the detailed description
The purpose of this study is to investigate the modulatory effect of a single session 20 min anodal primary motor cortex (M1) and cathodal primary somatosensory cortex (S1) transcranial direct current stimulation (tDCS) on the pain sensitivity on the descending part of musculus trapezius in healthy young adults.
- Conditions
- Healthy
- Being tested
- Active tDCS, Sham tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Using the 2-channel neuro-stimulator Sooma tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of the primary motor cortex (M1) with the cathode located over the right primary somatosensory cortex (S1).
Sham tDCSDevice
Using the 2-channel neuro-stimulator Sooma tDCS equipment we provide a sham stimulation with the anode place over the primary motor cortex (M1) and cathode located over the right primary somatosensory cortex (S1). The sham stimulation consists of 30 seconds of stimulation ramping up to a maximum of 2 mA, then 19 minutes of the device providing no stimulation and then ramping down from 2 mA intensity to 0 in the last 30 seconds. This configuration is designed to mimic the sensory experience of active tDCS.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Not described Receives: Device: Active tDCS |
| Sham tDCS | Placebo comparator | Not described Receives: Device: Sham tDCS |
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 was 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 descending part of the medial musculus trapezius sinister and dexter respectively.
Measured: Two assessments total: Once before the stimulation intervention (baseline assessment) and once again three minutes after the stimulation (post intervention assessment).
Secondary outcomes (1)
Change in Heat and Cold Pain Detection Thresholds
A 3×3 cm (9 cm2) contact thermode (Medoc Advanced Medical Systems, Israel) was used to apply thermal stimulation. Each stimulus will be started at 32°C and thresholds of heat and cold pain detection was assessed by ascending or descending ramps in temperature to the cutoffs of 0-50 °C. This will be assessed on the skin over the left side descending part of the medial musculus trapezius.
Measured: Two assessments total: Once before the stimulation intervention (baseline) and once again five minutes after the stimulation (post intervention assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Nov 2019
- Primary completion1 Dec 2020
- Study completion15 Feb 2021 (estimated)
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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., Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658485
- Sponsor's protocol ID
- N-20180085.p3
- Status last verified
- Jan 2021
- First submitted
- 23 Sep 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kold S, Kragh AJ, Graven-Nielsen CS, Elnegaard FS, Lund F, Vittrup IV, Cliff KL, Sivarooban R, Petrini L. Neuromodulation of somatosensory pain thresholds of the neck musculature using a novel transcranial direct current stimulation montage: a randomized double-blind, sham controlled study. Scand J Pain. 2022 Feb 7;22(3):622-630. doi: 10.1515/sjpain-2021-0187. Print 2022 Jul 26.
PubMed 35130374
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modulatory Effect of Anodal Primary Motor Cortex and Cathodal Primary Somatosensory Cortex Transcranial Direct Current Stimulation on Pain Thresholds in the Neck Musculature.
- ClinicalTrials.gov ID
- NCT04658485
- Acronym / sponsor ID
- N-20180085.p3
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Danish National Research Foundation
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 8 Dec 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.
The purpose of this study is to investigate the modulatory effect of a novel tDCS configuration on the pain sensitivity in healthy subjects.
Detailed description
The purpose of this study is to investigate the modulatory effect of a single session 20 min anodal primary motor cortex (M1) and cathodal primary somatosensory cortex (S1) transcranial direct current stimulation (tDCS) on the pain sensitivity on the descending part of musculus trapezius in healthy young adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Active tDCS |
| Sham tDCS | Placebo comparator | Device: Sham tDCS |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Age between 18-30 years
- Living in Denmark
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 |
|---|---|---|
| Active tDCSUsing the 2-channel neuro-stimulator Sooma tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of the primary motor cortex (M1) with the cathode located over the right primary somatosensory cortex (S1). | Device | Active tDCS |
| Sham tDCSUsing the 2-channel neuro-stimulator Sooma tDCS equipment we provide a sham stimulation with the anode place over the primary motor cortex (M1) and cathode located over the right primary somatosensory cortex (S1). The sham stimulation consists of 30 seconds of stimulation ramping up to a maximum of 2 mA, then 19 minutes of the device providing no stimulation and then ramping down from 2 mA intensity to 0 in the last 30 seconds. This configuration is designed to mimic the sensory experience of active tDCS. | Device | Sham tDCS |
Primary outcome
Change in pressure pain threshold
Time frame: Two assessments total: Once before the stimulation intervention (baseline assessment) and once again three minutes after the stimulation (post intervention assessment).
A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe was 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 descending part of the medial musculus trapezius sinister and dexter respectively.
1 secondary outcome
Change in Heat and Cold Pain Detection Thresholds
Time frame: Two assessments total: Once before the stimulation intervention (baseline) and once again five minutes after the stimulation (post intervention assessment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Derived from this study: PubMed 35130374Kold S, Kragh AJ, Graven-Nielsen CS, Elnegaard FS, Lund F, Vittrup IV, Cliff KL, Sivarooban R, Petrini L. Neuromodulation of somatosensory pain thresholds of the neck musculature using a novel transcranial direct current stimulation montage: a randomized double-blind, sham controlled study. Scand J Pain. 2022 Feb 7;22(3):622-630. doi: 10.1515/sjpain-2021-0187. Print 2022 Jul 26.
- 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.
Thomas Graven-Nielsen, Prof. study director
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 Active tDCS 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 3 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: status not confirmed, as of the sponsor's last update on 7 Jan 2021. 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?
Results are not available in the source record.
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: Two assessments total: Once before the stimulation intervention (baseline assessment) and once again three minutes after the stimulation (post intervention assessment).). 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 NCT04658485, 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 7 Jan 2021.