Trial Outcomes & Findings for Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS) (NCT NCT03049969)
NCT ID: NCT03049969
Last Updated: 2024-07-09
Results Overview
The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step
TERMINATED
NA
15 participants
End of treatment (up to 12 weeks)
2024-07-09
Participant Flow
Participant milestones
| Measure |
Cognitive Remediation
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)
Baseline characteristics by cohort
| Measure |
Cognitive Remediation
n=15 Participants
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
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|---|---|
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Age, Continuous
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46.33 years
STANDARD_DEVIATION 17.82 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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6 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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5 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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8 Participants
n=5 Participants
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Region of Enrollment
United States
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15 participants
n=5 Participants
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PRIMARY outcome
Timeframe: End of treatment (up to 12 weeks)The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step
Outcome measures
| Measure |
Cognitive Remediation
n=15 Participants
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
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|---|---|
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Number of Participants Completing at Least 80% of the Targeted Number of Sessions.
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10 Participants
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PRIMARY outcome
Timeframe: End of treatment (up to 12 weeks)Outcome measures
| Measure |
Cognitive Remediation
n=15 Participants
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
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|---|---|
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Number of Participants With Treatment Related Adverse Events
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14 Participants
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SECONDARY outcome
Timeframe: Baseline, end of treatment (up to 12 weeks)VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Outcome measures
| Measure |
Cognitive Remediation
n=12 Participants
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
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|---|---|
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Change in Visual Analogue Scale (VAS) for Pain Score
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-1.17 score on a scale
Standard Deviation 5.37
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SECONDARY outcome
Timeframe: Baseline, end of treatment (up to 12 weeks)This brief scale is comprised of 10 items measuring negative affect (e.g., upset, afraid). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The negative affect score is calculated by finding the sum of the 10 negative items. Scores range from 10 - 50. For the total negative score, a lower score indicates less of a negative affect.
Outcome measures
| Measure |
Cognitive Remediation
n=11 Participants
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
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|---|---|
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Change in Negative Affect Score From the Positive and Negative Affect Scale (PANAS)
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-3 score on a scale
Standard Deviation 5.74
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SECONDARY outcome
Timeframe: Baseline, end of treatment (up to 12 weeks)This brief scale is comprised of 10 items measuring positive affect (e.g., excited, inspired). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The positive affect score is calculated by finding the sum of the 10 positive items. Scores range from 10 - 50. For the total positive score, a higher score indicates more of a positive affect.
Outcome measures
| Measure |
Cognitive Remediation
n=12 Participants
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
|
|---|---|
|
Change in Positive Affect Score From the Positive and Negative Affect Scale (PANAS)
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-1.17 score on a scale
Standard Deviation 5.37
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SECONDARY outcome
Timeframe: Baseline, end of treatment (up to 12 weeks)The SDMT is a cognitive processing speed test. Participants are given a key of nine symbol-digit pairs along with a sequence of symbols. They are then asked to use the key to match as many symbols in the sequence to their corresponding numbers as possible within 90 seconds. The score is the number of correctly coded items from 0-110 in 90 seconds. Lower scores indicate cognitive decline.
Outcome measures
| Measure |
Cognitive Remediation
n=8 Participants
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
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|---|---|
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Change in Symbol Digit Modalities Test (SDMT) Score
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0.75 score on a scale
Standard Deviation 4.56
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Adverse Events
Cognitive Remediation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Remediation
n=15 participants at risk
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
tDCS stimulation: up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
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|---|---|
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Skin and subcutaneous tissue disorders
Tingling Sensation
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93.3%
14/15 • 12 Weeks
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Skin and subcutaneous tissue disorders
Itching Sensation
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93.3%
14/15 • 12 Weeks
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Skin and subcutaneous tissue disorders
Warmth Sensation
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93.3%
14/15 • 12 Weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place