Paired Acute Invasive/Non-invasive Stimulation Trial

NCT03954093 | Completed

• 1 other identifier: 13/SC/0298
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain scores: 21-point pain scale rating

  21-point pain scale rating

  Immediately after 30 minutes of transcranial direct current stimulation

Secondary Outcomes (2)

• Changes in EEG recordings

  Immediately after 30 minutes of transcranial direct current stimulation

• Changes in Facial Expression Recognition Performance

  Immediately after 30 minutes of transcranial direct current stimulation

Study Arms (3)

Sham stimulation

SHAM COMPARATOR

Device: Transcranial direct current stimulation

Motor cortex stimulation

ACTIVE COMPARATOR

Device: Transcranial direct current stimulation

MEG-localized stimulation

EXPERIMENTAL

Device: Transcranial direct current stimulation

Interventions

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.

Also known as: tDCS

MEG-localized stimulation; Motor cortex stimulation; Sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Alex Green, FRCS

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 17, 2019
• Study Start: May 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: April 6, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)