Trial Outcomes & Findings for Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation (NCT NCT03143894)
NCT ID: NCT03143894
Last Updated: 2021-05-12
Results Overview
Change in auditory working memory as measured by the PASAT prior to and following the intervention. PASAT scores range from 0 to 120, with higher scores reflecting better working memory. Larger positive change scores reflect greater improvement in performance from baseline whereas greater negative change scores reflect declines in performance from baseline.
TERMINATED
NA
7 participants
Baseline and Day 5
2021-05-12
Participant Flow
Participant milestones
| Measure |
Active tDCS First
2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days. This condition is followed by an active tDCS condition after a washout.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).
|
Sham tDCS First
Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days. This condition is followed by an active tDCS condition after a washout.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).
|
|---|---|---|
|
First Intervention (5 Days)
STARTED
|
3
|
4
|
|
First Intervention (5 Days)
COMPLETED
|
3
|
4
|
|
First Intervention (5 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (4 Weeks)
STARTED
|
3
|
4
|
|
Washout (4 Weeks)
COMPLETED
|
3
|
4
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (5 Days)
STARTED
|
3
|
4
|
|
Second Intervention (5 Days)
COMPLETED
|
3
|
3
|
|
Second Intervention (5 Days)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
Baseline characteristics by cohort
| Measure |
Active tDCS First
n=3 Participants
2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS)..
|
Sham tDCS First
n=4 Participants
Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days then active tDCS after washout.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS)..
|
Total
n=7 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
69 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
67.0 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 5Population: Participants who completed both active and sham conditions, allowing for calculation and comparison of change by condition.
Change in auditory working memory as measured by the PASAT prior to and following the intervention. PASAT scores range from 0 to 120, with higher scores reflecting better working memory. Larger positive change scores reflect greater improvement in performance from baseline whereas greater negative change scores reflect declines in performance from baseline.
Outcome measures
| Measure |
Active tDCS
n=6 Participants
2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).
|
Sham tDCS
n=6 Participants
Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).
|
|---|---|---|
|
Change on Paced Auditory Serial Attention Test (PASAT)
|
-1.83 raw score change on a scale
Standard Deviation 5.04
|
1.83 raw score change on a scale
Standard Deviation 14.52
|
SECONDARY outcome
Timeframe: Baseline and Day 5Population: Participants who completed both active and sham conditions, allowing for calculation and comparison of change by condition.
Change in subjective cognitive functioning as measured by the FACT-Cog Perceived Cognitive Impairment scale prior to and following the intervention. Raw scores range from 0 to 72, with higher scores reflecting better perceived cognitive functioning. Larger positive change scores reflect greater improvement in subjective cognitive functioning from baseline whereas greater negative change scores reflect declines in subjective cognitive functioning from baseline.
Outcome measures
| Measure |
Active tDCS
n=6 Participants
2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).
|
Sham tDCS
n=6 Participants
Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).
|
|---|---|---|
|
Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
|
7.17 raw score change on a scale
Standard Deviation 6.55
|
8.67 raw score change on a scale
Standard Deviation 12.03
|
SECONDARY outcome
Timeframe: Baseline and Day 5Population: Participants who completed both active and sham conditions, allowing for calculation and comparison of change by condition.
Change in subjective fatigue as measured by the MFSI-SF prior to and following the intervention. Raw scores range from -36 to + 144, with higher scores reflecting greater levels of fatigue. Larger positive change scores reflect greater improvement in fatigue from baseline whereas greater negative change scores reflect declines in fatigue from baseline.
Outcome measures
| Measure |
Active tDCS
n=6 Participants
2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).
|
Sham tDCS
n=6 Participants
Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).
|
|---|---|---|
|
Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF)
|
8.5 raw score change on a scale
Standard Deviation 6.02
|
14.83 raw score change on a scale
Standard Deviation 13.69
|
Adverse Events
Active tDCS
Sham tDCS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place