Neuropathic Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMultitarget tDCS
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.
DEVICESingle-target tDCS
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays.
DEVICESham tDCS
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.
Sponsors
Xuanwu Hospital, Beijing
Beijing Tiantan Hospital
Second Affiliated Hospital of Tsinghua University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female or males aged between 18 and 75 years. 2. Pain fulfilling the criteria for probable or definite neuropathic pain and scoring ≥4/10 at Douleur Neuropathique 4 Questions. 3. Pain duration of at least 3 months and average pain intensity scoring ≥4/10 at Numeric Rating Scale. 4. Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial. 5. Informed consent obtained.
Exclusion criteria
1. Pregnancy or lactation. 2. Active central nervous system diseases including but not limited to brain tumour, intracranial hypertension, past or current epilepsy. 3. Unable to complete the questionnaire due to language abilities or reduced cognitive functioning. 4. Alcohol or substance abuse. 5. Common contraindications for transcranial direct current stimulation including but not limited to skull defect, implanted device or metal in the brain, severe cardiopulmonary, renal or hepatic diseases. 6. Unwilling to comply with the treatment or follow-up assessments. 7. Participating in another clinical trial within 3 months prior to enrollment of this clinical trial. 8. Any patient deemed unsuitable for enrollment by the investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in average pain intensity | from baseline to week 2 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) | Week 2, Week 6, Week 10 | 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) |
Countries
China
Outcome results
None listed