PainNCT05711498
Non-invasive Modulation of Spinal Cord Nociceptive Reflexes
A study testing Transcutaneous spinal direct current stimulation (tsDCS) in people with Pain, run by Max Planck Research Group Pain Perception at 1 site in Germany.
Trial summary
The aims of this study are threefold. First, to investigate whether spinal nociceptive processing - represented here by the nociceptive flexion reflex (NFR) - is influenced by thoracic transcutaneous spinal direct current stimulation (tsDCS) in a spatially selective manner, i.e., whether effects are only observed for… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Transcutaneous spinal direct current stimulation (tsDCS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2022to 31 Dec 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between the ages of 18 and 40 years
- Having participated in the MRI medical assessment session and consented to taking part in 3T MRI measurements in written form
- Having participated in the magnetic/electric neurostimulation medical assessment session and consented to taking part in magnetic/electric neurostimulation experiments in written form
- Voluntary participation and signing of the study-specific consent form
Who cannot join
- Existence of any contraindications for MRI measurements and magnetic/electric neurostimulation experiments
- Pregnancy or breastfeeding
- Very dry or sensitive skin (e.g., intolerance to creams/shampoos)
- Chronic skin diseases - such as eczema or neurodermatitis - in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
- Scar tissue in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
- Acute sunburn in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
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- Current or recurring pain
- Injuries to the nervous system
- History of or current neurological or psychiatric disorders
- Chronic diseases that require permanent medication (e.g., asthma, diabetes mellitus, etc.)
- Persons not capable of giving consent (e.g., in case of dementia)
- Lack of consent with regards to report of incidental findings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Investigation of Excitability Changes in the Human Spinal Cord: the Effect of Transcutaneous Spinal Direct Current Stimulation (tsDCS) on Nociceptive Flexion Reflexes
The aims of this study are threefold. First, to investigate whether spinal nociceptive processing - represented here by the nociceptive flexion reflex (NFR) - is influenced by thoracic transcutaneous spinal direct current stimulation (tsDCS) in a spatially selective manner, i.e., whether effects are only observed for lower limb NFRs, but not for upper limb NFRs. Second, to investigate - in a double-blind, sham-controlled, within-participant design - whether anodal and cathodal tsDCS do affect the NFR in a polarity-dependent manner. Third, to investigate whether tsDCS effects observed on a spinal measure (NFR) are also observed in responses that are mediated supra-spinally, namely autonomic parameters and pain intensity ratings.
- Conditions
- Pain
- Being tested
- Transcutaneous spinal direct current stimulation (tsDCS)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal direct current stimulation (tsDCS)Other
tsDCS will be carried out using a direct current stimulator (DC-Stimulator Plus, neuroConn, Ilmenau, Germany), with one electrode placed above the thoracic spinal cord and the other electrode placed on the right shoulder. We will employ rectangular electrodes of 7 x 5 cm size (neuroConn, Ilmenau, Germany) covered by electrode paste (Ten20 Conductive Paste, Weaver and Company, Aurora, USA). Stimulation will consist of the following phases: a fade-in period of 15 seconds, a plateau period of 20 minutes (with stimulation at 2.5mA either anodally or cathodally) and a fade-out period of 15 seconds. Sham stimulation will follow the anodal montage with 15-second fade-in and fade-out periods, but only 45 seconds of plateau stimulation at 2.5 mA. Such a combination of stimulation and electrodes results in a current density of 0.071mA/cm2, well below thermal and histological limits for current density.
| Study group | Role | What they receive |
|---|---|---|
| Anodal thoracic tsDCS | Experimental | Anodal tsDCS will be applied over the T12 vertebra Receives: Other: Transcutaneous spinal direct current stimulation (tsDCS) |
| Cathodal thoracic tsDCS | Experimental | Cathodal tsDCS will be applied over the T12 vertebra Receives: Other: Transcutaneous spinal direct current stimulation (tsDCS) |
| Sham thoracic tsDCS | Sham comparator | Sham tsDCS will be applied over the T12 vertebra Receives: Other: Transcutaneous spinal direct current stimulation (tsDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NFR amplitude
90-150ms for lower limb, 60-200ms for upper limb
Measured: Baseline and immediately after the intervention
Change in pain intensity rating
One rating per trial on a standard visual analogue scale (VAS); internally numbered from 0 (no sensation) to 100 (unbearable pain)
Measured: Baseline and immediately after the intervention
Change in skin conductance response
Amplitude maximum before onset of pain rating
Measured: Baseline and immediately after the intervention
Change in heart period acceleration
Amplitude maximum before onset of pain rating
Measured: Baseline and immediately after the intervention
Secondary outcomes (1)
Change in NFR area
90-150ms for lower limb, 60-200ms for upper limb
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Planck Research Group Pain Perception
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711498
- Sponsor's protocol ID
- PP016
- Status last verified
- Mar 2023
- First submitted
- 10 Dec 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Investigation of Excitability Changes in the Human Spinal Cord: the Effect of Transcutaneous Spinal Direct Current Stimulation (tsDCS) on Nociceptive Flexion Reflexes
- ClinicalTrials.gov ID
- NCT05711498
- Acronym / sponsor ID
- PP016
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Max Planck Research Group Pain PerceptionUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Feb 2023 (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 aims of this study are threefold. First, to investigate whether spinal nociceptive processing - represented here by the nociceptive flexion reflex (NFR) - is influenced by thoracic transcutaneous spinal direct current stimulation (tsDCS) in a spatially selective manner, i.e., whether effects are only observed for lower limb NFRs, but not for upper limb NFRs. Second, to investigate - in a double-blind, sham-controlled, within-participant design - whether anodal and cathodal tsDCS do affect the NFR in a polarity-dependent manner. Third, to investigate whether tsDCS effects observed on a spinal measure (NFR) are also observed in responses that are mediated supra-spinally, namely autonomic parameters and pain intensity ratings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal thoracic tsDCS | Experimental | Other: Transcutaneous spinal direct current stimulation (tsDCS)Anodal tsDCS will be applied over the T12 vertebra |
| Cathodal thoracic tsDCS | Experimental | Other: Transcutaneous spinal direct current stimulation (tsDCS)Cathodal tsDCS will be applied over the T12 vertebra |
| Sham thoracic tsDCS | Sham comparator | Other: Transcutaneous spinal direct current stimulation (tsDCS)Sham tsDCS will be applied over the T12 vertebra |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers between the ages of 18 and 40 years
- Having participated in the MRI medical assessment session and consented to taking part in 3T MRI measurements in written form
- Having participated in the magnetic/electric neurostimulation medical assessment session and consented to taking part in magnetic/electric neurostimulation experiments in written form
- Voluntary participation and signing of the study-specific consent form
Key exclusion criteria (12 listed)
- Existence of any contraindications for MRI measurements and magnetic/electric neurostimulation experiments
- Pregnancy or breastfeeding
- Very dry or sensitive skin (e.g., intolerance to creams/shampoos)
- Chronic skin diseases - such as eczema or neurodermatitis - in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
- Scar tissue in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
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 |
|---|---|---|
| Transcutaneous spinal direct current stimulation (tsDCS)tsDCS will be carried out using a direct current stimulator (DC-Stimulator Plus, neuroConn, Ilmenau, Germany), with one electrode placed above the thoracic spinal cord and the other electrode placed on the right shoulder. We will employ rectangular electrodes of 7 x 5 cm size (neuroConn, Ilmenau, Germany) covered by electrode paste (Ten20 Conductive Paste, Weaver and Company, Aurora, USA). Stimulation will consist of the following phases: a fade-in period of 15 seconds, a plateau period of 20 minutes (with stimulation at 2.5mA either anodally or cathodally) and a fade-out period of 15 seconds. Sham stimulation will follow the anodal montage with 15-second fade-in and fade-out periods, but only 45 seconds of plateau stimulation at 2.5 mA. Such a combination of stimulation and electrodes results in a current density of 0.071mA/cm2, well below thermal and histological limits for current density. | Other | Anodal thoracic tsDCS, Cathodal thoracic tsDCS, Sham thoracic tsDCS |
Primary outcome
Change in NFR amplitude
Time frame: Baseline and immediately after the intervention
90-150ms for lower limb, 60-200ms for upper limb
Change in pain intensity rating
Time frame: Baseline and immediately after the intervention
One rating per trial on a standard visual analogue scale (VAS); internally numbered from 0 (no sensation) to 100 (unbearable pain)
Change in skin conductance response
Time frame: Baseline and immediately after the intervention
Amplitude maximum before onset of pain rating
Change in heart period acceleration
Time frame: Baseline and immediately after the intervention
Amplitude maximum before onset of pain rating
1 secondary outcome
Change in NFR area
Time frame: Baseline and immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- 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 Transcutaneous spinal direct current stimulation (tsDCS) in people with Pain, run by Max Planck Research Group Pain Perception at 1 site in Germany.
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 4 inclusion and 12 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 16 Mar 2023. 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 Germany. 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 NFR amplitude (time frame: Baseline and immediately after the intervention). The study lists 4 primary outcomes in all. 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 16 Mar 2023.