Paired Acute Invasive/Non-invasive Stimulation Trial

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: Transcranial direct current stimulation

• Registration Number: NCT03954093
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-05-01
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Transcranial direct current stimulation	-
Motor cortex stimulation	Transcranial direct current stimulation	-
MEG-localized stimulation	Transcranial direct current stimulation	-

Primary Outcome Measures

Name	Time	Method
Change in pain scores: 21-point pain scale rating	Immediately after 30 minutes of transcranial direct current stimulation	21-point pain scale rating

Secondary Outcome Measures

Name	Time	Method
Changes in EEG recordings	Immediately after 30 minutes of transcranial direct current stimulation	Changes in electrical fields of the cortex
Changes in Facial Expression Recognition Performance	Immediately after 30 minutes of transcranial direct current stimulation	An emotional categorisation task to identify anti-depressant effects

Trial Locations

Locations (1)

John Radcliffe Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom