- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03954093
Paired Acute Invasive/Non-invasive Stimulation Trial (PAINS)
April 2, 2020 updated by: University of Oxford
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oxfordshire
-
Oxford, Oxfordshire, United Kingdom, OX3 9DU
- John Radcliffe Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham stimulation
|
tDCS produces hyper/hypopolarizing potentials in the cortex underlying the scalp electrodes and can increase/decrease the excitability of targeted brain regions.
Other Names:
|
Active Comparator: Motor cortex stimulation
|
tDCS produces hyper/hypopolarizing potentials in the cortex underlying the scalp electrodes and can increase/decrease the excitability of targeted brain regions.
Other Names:
|
Experimental: MEG-localized stimulation
|
tDCS produces hyper/hypopolarizing potentials in the cortex underlying the scalp electrodes and can increase/decrease the excitability of targeted brain regions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Immediately after 30 minutes of transcranial direct current stimulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in EEG recordings
Time Frame: Immediately after 30 minutes of transcranial direct current stimulation
|
Changes in electrical fields of the cortex
|
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
|
An emotional categorisation task to identify anti-depressant effects
|
Immediately after 30 minutes of transcranial direct current stimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
December 20, 2019
Study Completion (Actual)
December 20, 2019
Study Registration Dates
First Submitted
May 10, 2019
First Submitted That Met QC Criteria
May 16, 2019
First Posted (Actual)
May 17, 2019
Study Record Updates
Last Update Posted (Actual)
April 6, 2020
Last Update Submitted That Met QC Criteria
April 2, 2020
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/SC/0298
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Patient diagnoses and demographics will be shared but identities kept anonymous
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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