Trial Outcomes & Findings for Pilot Study of Transcranial Stimulation (tDCS)to Relieve Neuropathic Pain in Cancer Patients (NCT NCT01948050)
NCT ID: NCT01948050
Last Updated: 2014-07-14
Results Overview
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).
COMPLETED
NA
24 participants
Assessed at baseline and post tDCS stimulation day 5
2014-07-14
Participant Flow
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.
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.
Participant milestones
| Measure |
Real tDCS Stimulation
non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
|
Overall Study
COMPLETED
|
16
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Real tDCS Stimulation
non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Pilot Study of Transcranial Stimulation (tDCS)to Relieve Neuropathic Pain in Cancer Patients
Baseline characteristics by cohort
| Measure |
Real tDCS Stimulation
n=16 Participants
non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
|
Sham tDCS
n=8 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
8 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline and post tDCS stimulation day 5Measured 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).
Outcome measures
| Measure |
Real tDCS Stimulation
n=16 Participants
non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
|
Sham tDCS
n=8 Participants
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.
|
|---|---|---|
|
Pain Intensity
|
1.66 Points on numerical rating scale
Standard Error 0.49
|
1.60 Points on numerical rating scale
Standard Error 0.74
|
Adverse Events
Real tDCS Stimulation
Sham tDCS
Serious adverse events
| Measure |
Real tDCS Stimulation
n=16 participants at risk
non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
|
Sham tDCS
n=8 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of shortness of breath
|
6.2%
1/16 • Number of events 2
|
12.5%
1/8 • Number of events 2
|
|
Gastrointestinal disorders
Exacerbation of Pain due to rectal cellulitis
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Transient change in mental status
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Real tDCS Stimulation
n=16 participants at risk
non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
|
Sham tDCS
n=8 participants at risk
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.
|
|---|---|---|
|
General disorders
Headache
|
12.5%
2/16 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Transient Pain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Interrupted Sleep
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Hypotension
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Dizziness
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Dry Mouth
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Numbness
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Worsening of Pain
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Tongue tingling
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Memory lapse
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
|
Ear and labyrinth disorders
Clear discharge from ear
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
|
Renal and urinary disorders
Urinary tract infection
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like symptoms
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tibial fracture
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place