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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham stimulation | Sham Comparator |
| |
| Motor cortex stimulation | Active Comparator |
| |
| MEG-localized stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain scores: 21-point pain scale rating | 21-point pain scale rating | Immediately after 30 minutes of transcranial direct current stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in EEG recordings | Changes in electrical fields of the cortex | Immediately after 30 minutes of transcranial direct current stimulation |
| Changes in Facial Expression Recognition Performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Green, FRCS | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
Patient diagnoses and demographics will be shared but identities kept anonymous
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2018 | May 13, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 28, 2018 | May 13, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
An emotional categorisation task to identify anti-depressant effects
| Immediately after 30 minutes of transcranial direct current stimulation |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |