Back to resultsPaired Acute Invasive/Non-invasive Stimulation Trial (PAINS)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- John Radcliffe Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Experimental
Arm Label
Sham stimulation
Motor cortex stimulation
MEG-localized stimulation
Arm Description
Outcomes
Primary Outcome Measures
Change in pain scores: 21-point pain scale rating
21-point pain scale rating
Secondary Outcome Measures
Changes in EEG recordings
Changes in electrical fields of the cortex
Changes in Facial Expression Recognition Performance
An emotional categorisation task to identify anti-depressant effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03954093
Brief Title
Paired Acute Invasive/Non-invasive Stimulation Trial
Acronym
PAINS
Official Title
Paired Transcranial Direct Current Stimulation/ Dorsal Root Ganglion Stimulation Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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 neuromodulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Title
Motor cortex stimulation
Arm Type
Active Comparator
Arm Title
MEG-localized stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
tDCS produces hyper/hypopolarizing potentials in the cortex underlying the scalp electrodes and can increase/decrease the excitability of targeted brain regions.
Primary Outcome Measure Information:
Title
Change in pain scores: 21-point pain scale rating
Description
21-point pain scale rating
Time Frame
Immediately after 30 minutes of transcranial direct current stimulation
Secondary Outcome Measure Information:
Title
Changes in EEG recordings
Description
Changes in electrical fields of the cortex
Time Frame
Immediately after 30 minutes of transcranial direct current stimulation
Title
Changes in Facial Expression Recognition Performance
Description
An emotional categorisation task to identify anti-depressant effects
Time Frame
Immediately after 30 minutes of transcranial direct current stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Green, FRCS
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patient diagnoses and demographics will be shared but identities kept anonymous
Learn more about this trial
Paired Acute Invasive/Non-invasive Stimulation Trial
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