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Completed

NCT Number: NCT03954093

Paired Acute Invasive/Non-invasive 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in EEG recordings

    Time frame: Immediately after 30 minutes of transcranial direct current stimulation

    Changes in electrical fields of the cortex

  2. 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

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Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Paired Transcranial Direct Current Stimulation/ Dorsal Root Ganglion Stimulation Trial

Acronym: PAINS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 17, 2019
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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