Chronic PainPAINSNCT03954093
Paired Acute Invasive/Non-invasive Stimulation Trial
A study testing Transcranial direct current stimulation in people with Chronic Pain, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Chronic pain patients with implanted dorsal root ganglion stimulators will be randomized to receive transcranial direct current stimulation (tDCS) to the motor cortex, magneto-encephalographically (MEG) localized stimulation or sham stimulation to identify therapeutic efficacy of paired central and peripheral… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- 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
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to 20 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are willing and able to give consent to the study.
- Male or Female, aged 18 years or above with diagnoses of chronic pain.
- Treatment includes Spinal Cord Stimulation, Dorsal Root Ganglion stimulation, or peripheral analgesic stimulation.
Who cannot join
- Patients who do not wish to be in the study.
- Patients with metallic intracranial implants.
- Patients with extreme language barrier that cannot understand the purpose of the study despite the use of an interpreter
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Paired Transcranial Direct Current Stimulation/ Dorsal Root Ganglion Stimulation Trial
Chronic pain patients with implanted dorsal root ganglion stimulators will be randomized to receive transcranial direct current stimulation (tDCS) to the motor cortex, magneto-encephalographically (MEG) localized stimulation or sham stimulation to identify therapeutic efficacy of paired central and peripheral neuromodulation.
- Conditions
- Chronic Pain
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called tDCS
tDCS produces hyper/hypopolarizing potentials in the cortex underlying the scalp electrodes and can increase/decrease the excitability of targeted brain regions.
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation | Sham comparator | Not described Receives: Device: Transcranial direct current stimulation |
| Motor cortex stimulation | Active comparator | Not described Receives: Device: Transcranial direct current stimulation |
| MEG-localized stimulation | Experimental | Not described Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores: 21-point pain scale rating
21-point pain scale rating
Measured: Immediately after 30 minutes of transcranial direct current stimulation
Secondary outcomes (2)
Changes in EEG recordings
Changes in electrical fields of the cortex
Measured: Immediately after 30 minutes of transcranial direct current stimulation
Changes in Facial Expression Recognition Performance
An emotional categorisation task to identify anti-depressant effects
Measured: Immediately after 30 minutes of transcranial direct current stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 May 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Green, FRCS, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954093
- Sponsor's protocol ID
- 13/SC/0298
- Acronym
- PAINS
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient diagnoses and demographics will be shared but identities kept anonymous
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Transcranial Direct Current Stimulation/ Dorsal Root Ganglion Stimulation Trial
- ClinicalTrials.gov ID
- NCT03954093
- Acronym / sponsor ID
- PAINS / 13/SC/0298
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 17 May 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.
Chronic pain patients with implanted dorsal root ganglion stimulators will be randomized to receive transcranial direct current stimulation (tDCS) to the motor cortex, magneto-encephalographically (MEG) localized stimulation or sham stimulation to identify therapeutic efficacy of paired central and peripheral neuromodulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation | Sham comparator | Device: Transcranial direct current stimulation |
| Motor cortex stimulation | Active comparator | Device: Transcranial direct current stimulation |
| MEG-localized stimulation | Experimental | Device: Transcranial direct current stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are willing and able to give consent to the study.
- Male or Female, aged 18 years or above with diagnoses of chronic pain.
- Treatment includes Spinal Cord Stimulation, Dorsal Root Ganglion stimulation, or peripheral analgesic stimulation.
Key exclusion criteria (3 listed)
- Patients who do not wish to be in the study.
- Patients with metallic intracranial implants.
- Patients with extreme language barrier that cannot understand the purpose of the study despite the use of an interpreter
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 stimulationAlso: tDCStDCS produces hyper/hypopolarizing potentials in the cortex underlying the scalp electrodes and can increase/decrease the excitability of targeted brain regions. | Device | MEG-localized stimulation, Motor cortex stimulation, Sham stimulation |
Primary outcome
Change in pain scores: 21-point pain scale rating
Time frame: Immediately after 30 minutes of transcranial direct current stimulation
21-point pain scale rating
2 secondary outcomes
Changes in EEG recordings
Time frame: Immediately after 30 minutes of transcranial direct current stimulation
Changes in Facial Expression Recognition Performance
Time frame: Immediately after 30 minutes of transcranial direct current stimulation
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 6 Apr 2020.
- Individual participant dataSharing planned: No. Patient diagnoses and demographics will be shared but identities kept anonymous
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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.
Alex Green, FRCS principal investigator
University of Oxford
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 Chronic Pain, run by University of Oxford at 1 site in United Kingdom.
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 3 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 6 Apr 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 United Kingdom. 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 pain scores: 21-point pain scale rating (time frame: Immediately after 30 minutes of transcranial direct current stimulation). 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 6 Apr 2020.