Trial Outcomes & Findings for Pilot Study of Transcranial Direct Current Stimulation (tDCS) (NCT NCT02746705)
NCT ID: NCT02746705
Last Updated: 2020-05-08
Results Overview
80% is equivalent to n=16 of the targeted 20 transcranial direct current stimulation (tDCS) or sham tDCS sessions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Four Weeks
Results posted on
2020-05-08
Participant Flow
Participant milestones
| Measure |
Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
Cognitive Training Program
|
Sham Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Cognitive Training Program
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
|
Overall Study
COMPLETED
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
Cognitive Training Program
|
Sham Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Cognitive Training Program
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
outlier scores deemed not valid
|
0
|
1
|
Baseline Characteristics
Missing measures were not administered by the study coordinator due to time limitations at visit. Fatigue assessment was prioritized as primary outcome, while the cognitive measures were collected for exploratory purposes to support power estimates to be used in potential future grant applications.
Baseline characteristics by cohort
| Measure |
Transcranial Direct Current Stimulation (tDCS)
n=15 Participants
Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
Cognitive Training Program
|
Sham Transcranial Direct Current Stimulation (tDCS)
n=12 Participants
Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Cognitive Training Program
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
44.8 years
STANDARD_DEVIATION 16.2 • n=15 Participants
|
43.4 years
STANDARD_DEVIATION 16.2 • n=12 Participants
|
44.1 years
STANDARD_DEVIATION 16.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants • Missing measures were not administered by the study coordinator due to time limitations at visit. Fatigue assessment was prioritized as primary outcome, while the cognitive measures were collected for exploratory purposes to support power estimates to be used in potential future grant applications.
|
8 Participants
n=12 Participants • Missing measures were not administered by the study coordinator due to time limitations at visit. Fatigue assessment was prioritized as primary outcome, while the cognitive measures were collected for exploratory purposes to support power estimates to be used in potential future grant applications.
|
16 Participants
n=27 Participants • Missing measures were not administered by the study coordinator due to time limitations at visit. Fatigue assessment was prioritized as primary outcome, while the cognitive measures were collected for exploratory purposes to support power estimates to be used in potential future grant applications.
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants • Missing measures were not administered by the study coordinator due to time limitations at visit. Fatigue assessment was prioritized as primary outcome, while the cognitive measures were collected for exploratory purposes to support power estimates to be used in potential future grant applications.
|
4 Participants
n=12 Participants • Missing measures were not administered by the study coordinator due to time limitations at visit. Fatigue assessment was prioritized as primary outcome, while the cognitive measures were collected for exploratory purposes to support power estimates to be used in potential future grant applications.
|
11 Participants
n=27 Participants • Missing measures were not administered by the study coordinator due to time limitations at visit. Fatigue assessment was prioritized as primary outcome, while the cognitive measures were collected for exploratory purposes to support power estimates to be used in potential future grant applications.
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants • n=4 total excluded from analyses: n=2 met stop criteria for study procedures, n=1 delayed in completing follow-up, n=1 outlier scores deemed not valid
|
4 Participants
n=4 Participants • n=4 total excluded from analyses: n=2 met stop criteria for study procedures, n=1 delayed in completing follow-up, n=1 outlier scores deemed not valid
|
9 Participants
n=9 Participants • n=4 total excluded from analyses: n=2 met stop criteria for study procedures, n=1 delayed in completing follow-up, n=1 outlier scores deemed not valid
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=10 Participants • n=4 total excluded from analyses: n=2 met stop criteria for study procedures, n=1 delayed in completing follow-up, n=1 outlier scores deemed not valid
|
8 Participants
n=8 Participants • n=4 total excluded from analyses: n=2 met stop criteria for study procedures, n=1 delayed in completing follow-up, n=1 outlier scores deemed not valid
|
18 Participants
n=18 Participants • n=4 total excluded from analyses: n=2 met stop criteria for study procedures, n=1 delayed in completing follow-up, n=1 outlier scores deemed not valid
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
12 Participants
n=12 Participants
|
27 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Four Weeks80% is equivalent to n=16 of the targeted 20 transcranial direct current stimulation (tDCS) or sham tDCS sessions.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation (tDCS)
n=15 Participants
Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
Cognitive Training Program
|
Sham Transcranial Direct Current Stimulation (tDCS)
n=12 Participants
Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Cognitive Training Program
|
|---|---|---|
|
The Number of Participants Completing at Least 80% of the Targeted Sessions.
|
15 participants
|
12 participants
|
PRIMARY outcome
Timeframe: Baseline, Four WeeksPopulation: 1 participant did not complete this session.
BICAMS comprises two tests, the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test-Revised (BVMT-R). Scoring for SDMT involves summing the number of correct substitutions within the 90 second interval (max = 110. The higher the score, the better). Visual/spatial memory is assessed in BICAMS using the BVMTR. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12 (the higher the score, the better). The total score range for BICAMS is 0-122. The higher the score, the better.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation (tDCS)
n=15 Participants
Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
Cognitive Training Program
|
Sham Transcranial Direct Current Stimulation (tDCS)
n=11 Participants
Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Cognitive Training Program
|
|---|---|---|
|
Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS)
|
0.12 score on a scale
Standard Deviation 0.47
|
0.29 score on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline, 4 WeeksPopulation: Some participants did not complete the MFIS session.
MFIS consists of 21 statements. The number that best indicates how often fatigue has affected the participant in the manner described during the past 4 weeks is circled. Answer choices include: 0 - never, 1 - rarely, 2 - sometimes, 3 - often, 4 - almost always. The total score ranges from 0 to 84. The higher the number, the more frequently fatigue impacted the participant during the past 4 weeks.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation (tDCS)
n=10 Participants
Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
Cognitive Training Program
|
Sham Transcranial Direct Current Stimulation (tDCS)
n=9 Participants
Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Cognitive Training Program
|
|---|---|---|
|
Change in Score on Modified Fatigue Impact Scale (MFIS)
|
-11.3 score on a scale
Standard Deviation 11.28
|
-0.44 score on a scale
Standard Deviation 20.81
|
SECONDARY outcome
Timeframe: Baseline, 4 WeekPopulation: Some participants did not complete the CBB session.
CBB is a brief, computer-administered cognitive test battery that requires approximately 10 minutes for administration. If the CBB score falls between -10 to +10, it is considered normal. CogState scoring is such that 0 could be considered as performing in the average range for that subtest compared to people of similar age. A negative score means that the performance was lower than average, and a positive score means the performance was higher than average. Higher positive scores (for instance 0.2 becoming 0.5) may indicate slightly better performance and higher negative scores (for instance, -0.4 becoming -0.8) may indicate slightly worsening performance.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation (tDCS)
n=14 Participants
Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
Cognitive Training Program
|
Sham Transcranial Direct Current Stimulation (tDCS)
n=8 Participants
Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Cognitive Training Program
|
|---|---|---|
|
Change in Score of CogState Brief Battery (CBB)
|
-0.02 score on a scale
Standard Deviation 0.05
|
-0.04 score on a scale
Standard Deviation 0.07
|
Adverse Events
Transcranial Direct Current Stimulation (tDCS)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Sham Transcranial Direct Current Stimulation (tDCS)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transcranial Direct Current Stimulation (tDCS)
n=17 participants at risk
Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
Cognitive Training Program
|
Sham Transcranial Direct Current Stimulation (tDCS)
n=14 participants at risk
Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Cognitive Training Program
|
|---|---|---|
|
General disorders
Tingling at electrode site
|
82.4%
14/17 • Number of events 139 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
78.6%
11/14 • Number of events 104 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
|
General disorders
Itching at electrode site
|
47.1%
8/17 • Number of events 56 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
35.7%
5/14 • Number of events 21 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
|
General disorders
Heat sensation at electrode site
|
47.1%
8/17 • Number of events 63 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
57.1%
8/14 • Number of events 68 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
|
General disorders
headache
|
17.6%
3/17 • Number of events 4 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
21.4%
3/14 • Number of events 11 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
|
General disorders
Facial muscle twitching
|
5.9%
1/17 • Number of events 1 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
0.00%
0/14 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
|
General disorders
Blurred vision
|
0.00%
0/17 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
7.1%
1/14 • Number of events 1 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
|
General disorders
Localized head pain
|
11.8%
2/17 • Number of events 14 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
7.1%
1/14 • Number of events 2 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
|
General disorders
Forgetfulness
|
11.8%
2/17 • Number of events 2 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
0.00%
0/14 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
|
General disorders
Difficulty concentrating
|
11.8%
2/17 • Number of events 2 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
14.3%
2/14 • Number of events 2 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
|
General disorders
Dizziness
|
0.00%
0/17 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
7.1%
1/14 • Number of events 14 • 4 Weeks
side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place