Pain
Conditions
Brief summary
This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who developed neuropathic pain in the affected area after a surgical intervention, radiation therapy, or chemotherapy to treat the disease.
Detailed description
This is a pilot study that aims to determine the effect of repetitive tDCS stimulation, performed on five consecutive days at intensity of 2 mA, on pain and somatosensory abnormalities in patients with neuropathic pain that followed surgical, radiation or chemotherapeutic treatment, and to evaluate safety of tDCS in the same model.
Interventions
Sponsors
Beth Israel Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult male and female patients with cancer who developed neuropathic pain in the affected area secondary the surgical procedure, chemotherapy or radiation that meet the following Inclusion/
Exclusion criteria
Inclusion Criteria: Pain on the side of the lesion * Spontaneous pain with a score for worst pain in the last 24 hours \>4 on a numeric scale 0-10 * Must present the following symptoms and signs: * Continuous burning, shooting, or lancinating pain. * Presence of hyperesthesia * Presence of hyperalgesia (to pinprick) and/or allodynia (to light touch)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Assessed at baseline and post tDCS stimulation day 5 | Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure Pain intensity assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2). |
Countries
United States
Participant flow
Recruitment details
191 subjects identified. 33 were ineligible at pre-screening; 40 not reacahble; 21 lost to follow-up; 3 deceased; 56 not interested. 38 subjects consented.
Pre-assignment details
38 subjects consented; 8 screen failures; 6 never started; 24 were randomized. 1 subject withdrew after undergoing 4 of 5 tDCS/sham sessions. 23 completed randomized study.
Participants by arm
| Arm | Count |
|---|---|
| Real tDCS Stimulation non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days. | 16 |
| Sham tDCS sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days. | 8 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Sham tDCS | Real tDCS Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 13 Participants | 21 Participants |
| Age, Continuous | 49.8 years STANDARD_DEVIATION 13.4 | 56.9 years STANDARD_DEVIATION 9.4 | 54.5 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 8 participants | 16 participants | 24 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 16 | 5 / 8 |
| serious Total, serious adverse events | 1 / 16 | 1 / 8 |
Outcome results
Primary
Pain Intensity
Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure Pain intensity assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2).
Time frame: Assessed at baseline and post tDCS stimulation day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real tDCS Stimulation | Pain Intensity | 1.66 Points on numerical rating scale | Standard Error 0.49 |
| Sham tDCS | Pain Intensity | 1.60 Points on numerical rating scale | Standard Error 0.74 |