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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| Second Affiliated Hospital of Tsinghua University | OTHER |
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This study aims to conduct a randomized controlled trial to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) on pain, depression, anxiety, quality of life and sleep, in patients with neuropathic pain.
The present multicenter, randomized, double-blind, sham-controlled, parallel-group trial aims to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) in patients with neuropathic pain.
The patients will be randomized to receive one of 3 treatment arms: multitarget stimulation, single-target stimulation and sham stimulation. All patients received 20 minutes of active or sham tDCS once a day for 10 consecutive weekdays. In multitarget group, subjects will receive 2mA tDCS applied to M1 and DLPFC alternately, with each target stimulated for 5 sessions. In single-target group, 2mA tDCS will target M1 only. In sham group, subjects will receive sham tDCS. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mutitarget tDCS | Experimental | Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to DLPFC and M1 alternately for ten consecutive weekdays, with each target stimulated for 5 sessions. |
|
| Single-target tDCS | Experimental | Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays. |
|
| Sham tDCS | Sham Comparator | Subjects will receive 20 minutes of sham transcranial direct current stimulation. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps. Subjects will undergo stimulation once a day for ten consecutive weekdays. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mutitarget tDCS | Device | Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to DLPFC and M1 alternately for ten consecutive weekdays, with each target stimulated for 5 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average pain intensity | Change in average pain intensity from baseline to week 2, average pain intensity corresponds to average pain over the last 24 hours on the Brief Pain Inventory | from baseline to week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Pain Inventory (BPI): Average pain over the last 24 hours | from baseline to week 6 and week 10 | |
| Change in BPI: Maximal pain over the last 24 hours | from baseline to week 2, week 6 and week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| Single-target tDCS | Device | Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays. |
|
| Sham tDCS | Device | Subjects will receive 20 minutes of sham transcranial direct current stimulation. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps. Subjects will undergo stimulation once a day for ten consecutive weekdays. |
|
| Change in BPI: Minimal pain over the last 24 hours | from baseline to week 2, week 6 and week 10 |
| Change in Neuropathic Pain Symptoms Inventory (NPSI): Burning pain | from baseline to week 2, week 6 and week 10 |
| Change in NPSI: Deep pain | from baseline to week 2, week 6 and week 10 |
| Change in NPSI: Paroxysmal pain | from baseline to week 2, week 6 and week 10 |
| Change in NPSI: Evoked pain | from baseline to week 2, week 6 and week 10 |
| Change in NPSI: Paraesthesia | from baseline to week 2, week 6 and week 10 |
| Change in Hamilton Depression Scale (HAMD) | from baseline to week 2, week 6 and week 10 |
| Change in Hamilton Anxiety Scale (HAMA) | from baseline to week 2, week 6 and week 10 |
| Change in Pittsburgh sleep quality index (PSQI) | from baseline to week 6 and week 10 |
| Change in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L): EQ-VAS | from baseline to week 2, week 6 and week 10 |
| Change in EQ-5D-5L: Utility score | from baseline to week 2, week 6 and week 10 |
| Proportion of participants with meaningful improvement compared with baseline (score as 1 or 2) in Patient Global Impression of Change (PGIC) | PGIC includes 7 ranks ranging from 1 to7 (1= very much improved; 2= moderately improved; 3=slightly improved; 4= no change; 5= slightly worsened; 6= moderately worsened; 7= very much worsened) | Week 2, Week 6, Week 10 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |