Paired Acute Invasive/Non-invasive Stimulation Trial

Chronic Pain Clinical Trial

— PAINS  

Official title:

Paired Transcranial Direct Current Stimulation/ Dorsal Root Ganglion Stimulation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954093
• Other study ID #: 13/SC/0298
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: May 2019
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Transcranial direct current stimulation
tDCS produces hyper/hypopolarizing potentials in the cortex underlying the scalp electrodes and can increase/decrease the excitability of targeted brain regions.

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain scores: 21-point pain scale rating	21-point pain scale rating	Immediately after 30 minutes of transcranial direct current stimulation
Secondary	Changes in EEG recordings	Changes in electrical fields of the cortex	Immediately after 30 minutes of transcranial direct current stimulation
Secondary	Changes in Facial Expression Recognition Performance	An emotional categorisation task to identify anti-depressant effects	Immediately after 30 minutes of transcranial direct current stimulation