Prolonged PainNCT04165980
Modulatory Effects of Multichannel tDCS During Prolonged Experimental Pain
A study testing transcranial direct current stimulation in people with Prolonged Pain and Neuroplasticity, run by Aalborg University at 1 site in Denmark.
Trial summary
Corticomotor excitability, pain sensitivity, descending pain control and somatosensory evoked potentials (SEPs) is often altered in acute and chronic pain. Topical capsaicin generates stable, long-lasting hyperalgesia and ongoing tonic pain in healthy participants, which significantly inhibits corticomotor… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prolonged Pain, Neuroplasticity, Brain Modulation
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2019to 28 Feb 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Right-handed healthy men and women in the age 21-50 years who speak and understand English
Who cannot join
- Lack of ability to cooperate
- History of chronic pain or current acute pain
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Present and previous neurologic, musculoskeletal or mental illnesses
- Chili allergies (subproject 1 and 2)
Show all 11Show fewer
- Current use of medications that may affect the trial
- Previous experience with rTMS and tDCS
- Contraindications to rTMS application (history of epilepsy, metal implants in head or jaw, etc.)
- Failure to pass the questionnaire for tDCS
- Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen) (Rossi et al., 2001)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Non-invasive Brain Stimulation Methods in Experimentally Induced Pain
Corticomotor excitability, pain sensitivity, descending pain control and somatosensory evoked potentials (SEPs) is often altered in acute and chronic pain.
Topical capsaicin generates stable, long-lasting hyperalgesia and ongoing tonic pain in healthy participants, which significantly inhibits corticomotor excitability in the primary motor cortex (M1).
Read more
Recent studies (by Fischer et al 2017) indicated that multifocal Transcranial Direct Current Stimulation (tDCS) administered to brain regions linked to the resting state motor network (network-tDCS) could enhance corticomotor excitability in healthy participants compared to single site M1-tDCS.
It remains unknown whether network-tDCS has also the potential to modulate the inhibitory effects on motor cortex excitability, pain sensitivity, descending pain control and SEPs associated with prolonged pain
Read the detailed description
To date, pain modulation to M1 rs-network tDCS during 8% capsaicin induced pain has not been assessed (Mylius, Borckardt and Lefaucheur, 2012). Further, it is unknown how multichannel tDCS acts on tonic cutaneous pain for approximately 24 hours.
The main objective of these projects are to study and characterize quantitatively the effects of multichannel tDCS in the development of prolonged pain.
It is hypothesized that multichannel tDCS of left M1 resting-state network will reduce the severity of experimentally prolonged pain over the m. first dorsal interosseous (FDI), will increase descending pain control, might possibly increase pain thresholds and simultaneously will modulate the peak-to-peak amplitude of SEPs to electrical painful stimulation. Further, it is hypothesized that descending pain modulation of M1 tDCS will be related to interference with the suppression of cortical excitability
- Conditions
- Prolonged Pain, Neuroplasticity, Brain Modulation
- Being tested
- transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Transcranial direct current stimulation delivers a low intensity current of up to 4 mA per session through small and circular shaped electrodes applied over the scalp. This induces a weak but focal electrical field that may modify the excitability of the underlying cortical target in a polarity and activity dependent fashion.
| Study group | Role | What they receive |
|---|---|---|
| Sham transcranial direct current stimulation (sham tDCS) | Sham comparator | This study has a parallel design and 2 groups: Active tDCS and Sham tDCS. Sham tDCS applies a standard sham protocol consisting of ramping up and down during 30 seconds at the beginning and at the end of each tDCS session. Each tDCS session lasts 20 minutes and applies a total current of 4mA. Receives: Device: transcranial direct current stimulation |
| Active transcranial direct current stimulation (activetDCS) | Active comparator | The active comparator is the Active tDCS group. The active tDCS will target the resting-state motor network and will apply a distributed direct current during the whole session. (The TIME during the direct current is applied is the only difference with Sham tDCS) Each tDCS session lasts 20 minutes and applies a total current of 4mA. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticomotor excitability
Corticomotor excitability is expressed as the peak-to-peak amplitude of motor evoked potentials to single-pulse transcranial magnetic stimulation. It is expected that network-tDCS will reduce corticomotor inhibition induced by tonic pain during 24 hours.
Measured: 24 hours
Secondary outcomes (7)
Conditioned pain modulation effect
Conditioned pain modulation effect is an indicator of descending inhibitory control in humans. In this study, it is performed using pressure cuff algometry. The CPM protocol consisted of a constant cuff pressure stimulation (conditioning stimulus) at 70% of the PTT (recorded for pain sensitivity assessment on that day) applied to the left leg and simultaneously one ramped cuff stimulation (test stimulus) at 1 kPa/s applied to the right leg. It is hypothesized that network-tDCS might normalize the CPM effect reduced by tonic pain during 24 hours.
Measured: 24 hours
Warm detection thresholds (sensitivity measure)
Warm detection thresholds will be assessed using a thermode applied on the volar forearm. The thermode will start increasing the temperature from 32 C (Celsius degrees) until the participant can detect a warm sensation and will immediately press a stop button. This task will be repeted a total of 4 times.
It is hypothesized that 2 daily treatments of active network-tDCS will not modulate this sensitivity measure during prolonged pain due to a small effect size.
Measured: 24 hours
Heat pain thresholds (pain sensitivity measure)
Heat pain thresholds will be assessed using a thermode applied on the volar forearm. The thermode will start increasing the temperature from 32 C (Celsius degrees) until the participant can detect a temperature increment from just "a warm sensation" to an additional of either "burning" or "painful" and will immediately press a stop button. This task will be repeted a total of 3 times.
It is hypothesized that 2 daily treatments of active network-tDCS will not modulate this pain sensitivity measure during prolonged pain due to a small effect size.
Measured: 24 hours
Mechanical pain thresholds (pain sensitivity measure)
Mechanical pain thresholds (MPT) were assessed using seven pinprick stimulators (MRC Systems GmbH, Germany) exerting forces ranging from 8 mN to 512 mN over the distal part of the volar forearm. Starting with the lightest, each stimulator is applied in an ascending order until the participant reported a perception of sharpness or pain. If the pain threshold is not reached, the value of 1024 mN was registered. The MPT will be expressed as the geometric mean of five series of ascending/descending series of stimuli.
It is hypothesized that 2 daily treatments of active network-tDCS will not modulate this pain sensitivity measure during prolonged pain due to a small effect size.
Measured: 24 hours
Cuff pressure pain sensitivity
A computer-controlled cuff algometer combined with two 10-cm wide air-pressured cuffs and an electronic visual analogue scale (eVAS; anchored at 0 cm [no pain] and 10 cm [worst pain imaginable]) are used to assess cuff pressure pain detection thresholds (PDT) and pain tolerance thresholds (PTT).
It is hypothesized that 2 daily treatments of active network-tDCS will not modulate these pain sensitivity measures during prolonged pain due to a small effect size.
Measured: 24 hours
Amplitude of SEPs to electrical painful stimulation
It is expected that the peak to peak amplitude of SEPs (in Cz position) will be modulated by tonic pain during 24 hours and by network-tDCS.
Measured: 24 hours
Latency of SEPs to electrical painful stimulation
it is expected that the latency of SEPs will remain unchanged during the 24 hours period and will not be affected by neither prolonged pain nor by network-tDCS.
Measured: 24 hours
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 start1 Mar 2019
- Primary completion30 Nov 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged 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
- The current studies have a randomized, parallel, sham-controlled and double-blinded design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luisina Gregoret, Aalborg University
- Investigators
- Thomas Graven-Nielsen, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165980
- Sponsor's protocol ID
- VN-20180092
- Status last verified
- Jun 2020
- First submitted
- 14 Nov 2019
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Brain Stimulation Methods in Experimentally Induced Pain
- ClinicalTrials.gov ID
- NCT04165980
- Acronym / sponsor ID
- VN-20180092
- Conditions
- Prolonged Pain, Neuroplasticity, Brain Modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 28 Feb 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.
Corticomotor excitability, pain sensitivity, descending pain control and somatosensory evoked potentials (SEPs) is often altered in acute and chronic pain.
Topical capsaicin generates stable, long-lasting hyperalgesia and ongoing tonic pain in healthy participants, which significantly inhibits corticomotor excitability in the primary motor cortex (M1).
Recent studies (by Fischer et al 2017) indicated that multifocal Transcranial Direct Current Stimulation (tDCS) administered to brain regions linked to the resting state motor network (network-tDCS) could enhance corticomotor excitability in healthy participants compared to single site M1-tDCS.
It remains unknown whether network-tDCS has also the potential to modulate the inhibitory effects on motor cortex excitability, pain sensitivity, descending pain control and SEPs associated with prolonged pain
Detailed description
To date, pain modulation to M1 rs-network tDCS during 8% capsaicin induced pain has not been assessed (Mylius, Borckardt and Lefaucheur, 2012). Further, it is unknown how multichannel tDCS acts on tonic cutaneous pain for approximately 24 hours.
The main objective of these projects are to study and characterize quantitatively the effects of multichannel tDCS in the development of prolonged pain.
It is hypothesized that multichannel tDCS of left M1 resting-state network will reduce the severity of experimentally prolonged pain over the m. first dorsal interosseous (FDI), will increase descending pain control, might possibly increase pain thresholds and simultaneously will modulate the peak-to-peak amplitude of SEPs to electrical painful stimulation. Further, it is hypothesized that descending pain modulation of M1 tDCS will be related to interference with the suppression of cortical excitability
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The current studies have a randomized, parallel, sham-controlled and double-blinded design.
| Arm | Type | Receives |
|---|---|---|
| Sham transcranial direct current stimulation (sham tDCS) | Sham comparator | Device: transcranial direct current stimulationThis study has a parallel design and 2 groups: Active tDCS and Sham tDCS. Sham tDCS applies a standard sham protocol consisting of ramping up and down during 30 seconds at the beginning and at the end of each tDCS session. Each tDCS session lasts 20 minutes and applies a total current of 4mA. |
| Active transcranial direct current stimulation (activetDCS) | Active comparator | Device: transcranial direct current stimulationThe active comparator is the Active tDCS group. The active tDCS will target the resting-state motor network and will apply a distributed direct current during the whole session. (The TIME during the direct current is applied is the only difference with Sham tDCS) Each tDCS session lasts 20 minutes and applies a total current of 4mA. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Right-handed healthy men and women in the age 21-50 years who speak and understand English
Key exclusion criteria (11 listed)
- Lack of ability to cooperate
- History of chronic pain or current acute pain
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Present and previous neurologic, musculoskeletal or mental illnesses
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 |
|---|---|---|
| transcranial direct current stimulationTranscranial direct current stimulation delivers a low intensity current of up to 4 mA per session through small and circular shaped electrodes applied over the scalp. This induces a weak but focal electrical field that may modify the excitability of the underlying cortical target in a polarity and activity dependent fashion. | Device | Active transcranial direct current stimulation (activetDCS), Sham transcranial direct current stimulation (sham tDCS) |
Primary outcome
Corticomotor excitability
Time frame: 24 hours
Corticomotor excitability is expressed as the peak-to-peak amplitude of motor evoked potentials to single-pulse transcranial magnetic stimulation. It is expected that network-tDCS will reduce corticomotor inhibition induced by tonic pain during 24 hours.
7 secondary outcomes
Conditioned pain modulation effect
Time frame: 24 hours
Warm detection thresholds (sensitivity measure)
Time frame: 24 hours
Heat pain thresholds (pain sensitivity measure)
Time frame: 24 hours
Mechanical pain thresholds (pain sensitivity measure)
Time frame: 24 hours
Cuff pressure pain sensitivity
Time frame: 24 hours
Amplitude of SEPs to electrical painful stimulation
Time frame: 24 hours
Latency of SEPs to electrical painful stimulation
Time frame: 24 hours
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 24 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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, PhD 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 transcranial direct current stimulation in people with Prolonged 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 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 24 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?
Corticomotor excitability (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2020.