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

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:
  • tDCS
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:
  • tDCS
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:
  • tDCS

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.

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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