Trial Outcomes & Findings for Non-invasive Stimulation of Brain Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia (NCT NCT03422250)
NCT ID: NCT03422250
Last Updated: 2021-05-19
Results Overview
CDR - Clinical Dementia Rating score The clinical dementia rating (CDR) is a clinical global rating scale administered to both the participant and the caregiver, assessing 6 domains of participant function: memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care. Each domain is based on a 5-point scale ranging from no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 to severe impairment=3. The global CDR score is computed via a memory-weighted averaging algorithm of the six domain scores and ranges from 0 to 5. The CDR-sum of boxes (CDR-SB) is the sum of the individual domain scores and ranges from 0 to 18. Higher scores indicate more clinical impairment. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline, post tDCS (week 3)
Results posted on
2021-05-19
Participant Flow
Participant milestones
| Measure |
AD: Anodal tDCS of the DMN
Alzheimer's disease (AD): anodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
Alzheimer's disease (AD): cathodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
Behavioral-variant frontotemporal dementia (bvFTD): anodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
Behavioral-variant frontotemporal dementia (bvFTD): cathodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Intervention
STARTED
|
11
|
11
|
12
|
11
|
|
Intervention
COMPLETED
|
10
|
10
|
10
|
10
|
|
Intervention
NOT COMPLETED
|
1
|
1
|
2
|
1
|
|
Follow-up
STARTED
|
10
|
10
|
10
|
10
|
|
Follow-up
COMPLETED
|
10
|
10
|
10
|
8
|
|
Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
AD: Anodal tDCS of the DMN
Alzheimer's disease (AD): anodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
Alzheimer's disease (AD): cathodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
Behavioral-variant frontotemporal dementia (bvFTD): anodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
Behavioral-variant frontotemporal dementia (bvFTD): cathodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Intervention
Adverse Event
|
0
|
1
|
0
|
1
|
|
Intervention
safety (psoriasis, cortical vascular lesions on MRI)
|
1
|
0
|
2
|
0
|
|
Follow-up
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Follow-up
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Non-invasive Stimulation of Brain Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia
Baseline characteristics by cohort
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode (DMN) network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=10 Participants
bvFTD: anodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=10 Participants
bvFTD: cathodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 6 • n=5 Participants
|
73 years
STANDARD_DEVIATION 6 • n=7 Participants
|
71 years
STANDARD_DEVIATION 10 • n=5 Participants
|
69 years
STANDARD_DEVIATION 11 • n=4 Participants
|
71 years
STANDARD_DEVIATION 8 • n=21 Participants
|
|
Sex/Gender, Customized
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
CDR - Clinical Dementia Rating score The clinical dementia rating (CDR) is a clinical global rating scale administered to both the participant and the caregiver, assessing 6 domains of participant function: memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care. Each domain is based on a 5-point scale ranging from no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 to severe impairment=3. The global CDR score is computed via a memory-weighted averaging algorithm of the six domain scores and ranges from 0 to 5. The CDR-sum of boxes (CDR-SB) is the sum of the individual domain scores and ranges from 0 to 18. Higher scores indicate more clinical impairment. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=10 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=10 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Clinical Disease Severity (CDR)
CDR global
|
-0.1 score on a scale
Standard Deviation 0.2
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Change in Clinical Disease Severity (CDR)
CDR sum of boxes
|
0.1 score on a scale
Standard Deviation 0.4
|
0.0 score on a scale
Standard Deviation 0.2
|
-0.1 score on a scale
Standard Deviation 0.3
|
0.0 score on a scale
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
The Neuropsychiatric Inventory (NPI) is a behavioral scale administered to the caregiver assessing 12 dimensions: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor activity, nighttime behaviors, and appetite/eating. Each dimension has multiple screening questions relating to symptoms. If the answer to the screening questions is "Yes", the dimensional-score is the product of frequency (1=occasionally to 4=very frequently) and severity (1=Mild to 3=Severe) of symptoms. Dimensional-scores are summed (from 0 to 144). Higher scores indicate greater behavioral disturbances. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=10 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=10 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Behavioral Symptom Severity (NPI)
|
-1 score on a scale
Standard Deviation 3
|
-3 score on a scale
Standard Deviation 6
|
-1 score on a scale
Standard Deviation 4
|
-6 score on a scale
Standard Deviation 11
|
PRIMARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
The Frontal Behavioral Inventory (FBI) is a 24-item inventory designed to assess behavior and personality changes via caregiver. Item-level scores range from 0=none, 1=mild/occasional, 2=moderate, 3=severe/most of the time. Item-scores are summed (from 0 to 72). Higher scores indicate greater behavioral/personality disturbances. Negative changes at post tDCS compared to baseline represent an improvement on the scale.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Behavioral Symptom Severity (FBI)
|
-2 score on a scale
Standard Deviation 4
|
-4 score on a scale
Standard Deviation 8
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
Default mode network (DMN) and salience network (SN) mean functional connectivity is assessed on resting state functional MRI. Functional connectivity is standardized to Z scores and thresholded at Z\>2. Higher values denote greater functional connectivity. A positive change at post tDCS compared to baseline represents an increase in resting-state functional connectivity.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=9 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=9 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Functional Connectivity
DMN
|
0.08 Z-score
Standard Deviation 0.13
|
-0.09 Z-score
Standard Deviation 0.11
|
-0.02 Z-score
Standard Deviation 0.23
|
-0.04 Z-score
Standard Deviation 0.15
|
|
Change in Functional Connectivity
SN
|
-0.06 Z-score
Standard Deviation 0.15
|
0.05 Z-score
Standard Deviation 0.2
|
0.08 Z-score
Standard Deviation 0.18
|
0.02 Z-score
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
Default mode network (DMN) and salience network (SN) mean cerebral blood flow is assessed on arterial spin labeling. Cerebral blood flow is computed by averaging values across the DMN and SN regions of interest. Cerebral blood flow is a measure of brain perfusion, higher values denoting higher perfusion. A positive change at post tDCS compared to baseline represents an increase in perfusion.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=9 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=9 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=7 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=9 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Cerebral Blood Flow
DMN
|
4.87 ml/100g/min
Standard Deviation 8.92
|
-0.06 ml/100g/min
Standard Deviation 9.46
|
0.56 ml/100g/min
Standard Deviation 7.72
|
3.08 ml/100g/min
Standard Deviation 3.45
|
|
Change in Cerebral Blood Flow
SN
|
4.37 ml/100g/min
Standard Deviation 7.00
|
-1.92 ml/100g/min
Standard Deviation 12.3
|
2.34 ml/100g/min
Standard Deviation 4.84
|
1.41 ml/100g/min
Standard Deviation 4.09
|
SECONDARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
The composite memory score consists of the averaged Z-standardized scores of 5 memory tests: immediate and delayed auditory verbal learning test recall, Rey-Osterrieth complex figure recall, story recall, digit span backward and forward tests. Each test score is normalized to an independent dataset of healthy controls. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better memory performance. Positive changes at post tDCS compared to baseline represent an improvement in memory.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=10 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=10 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Cognition: Memory
|
0.3 z score
Standard Deviation 0.2
|
0.3 z score
Standard Deviation 0.3
|
0.1 z score
Standard Deviation 0.3
|
0.2 z score
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
The composite language score consists of the averaged Z-standardized scores of 2 language tests: verbal fluency and token tests. Each test score is normalized to an independent dataset of healthy controls. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better language performance. Positive changes at post tDCS compared to baseline represent an improvement in language.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=10 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=10 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Cognition: Language
|
0.7 z score
Standard Deviation 0.6
|
0.4 z score
Standard Deviation 0.6
|
0.7 z score
Standard Deviation 0.9
|
0.4 z score
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
The composite executive function score consists of the averaged Z-standardized scores of 2 executive functions tests: trail making test part A and part B tests. Each test score is normalized to an independent dataset of healthy controls and inverted. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better executive function performance. Positive changes at post tDCS compared to baseline represent an improvement in executive functions.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=10 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=10 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Cognition: Executive Function
|
0.3 z score
Standard Deviation 2.9
|
-0.3 z score
Standard Deviation 2.4
|
0.7 z score
Standard Deviation 2.3
|
-0.7 z score
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
The visuospatial function score consists of the Z-standardized scores for the Rey-Osterrieth complex figure copy test. Scores are normalized to an independent dataset of healthy controls. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better visuospatial performance. Positive changes at post tDCS compared to baseline represent an improvement in visuospatial functions.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=10 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=10 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Cognition: Visuospatial Function
|
1.2 z score
Standard Deviation 1.1
|
0.0 z score
Standard Deviation 1.6
|
0.1 z score
Standard Deviation 0.8
|
0.4 z score
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
The composite emotion recognition score consists of the averaged Z-standardized scores for 2 emotion recognition tests: reading the Mind in the Eyes and 60 Ekman faces tests. Each test score is normalized to an independent dataset of healthy controls. Z-scores have no minimum/maximum values. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote better emotion recognition performance. Positive changes at post tDCS compared to baseline represent an improvement in emotion recognition.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=10 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=10 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Cognition: Emotion Recognition
|
0.1 z score
Standard Deviation 0.5
|
0.1 z score
Standard Deviation 0.6
|
0.3 z score
Standard Deviation 1.2
|
0.1 z score
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
Fractional anisotropy (FA) is assessed on diffusion weighted imaging. FA values are averaged in default mode network (DMN) and salience network (SN) regions of interest. FA values denote the directionality of water diffusivity, ranging from 0 (isotropic diffusion) to 1 (anisotropic diffusion). Higher values denote higher directionality and connectivity. Positive changes at post tDCS compared to baseline represent an improvement in the measure.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=9 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=7 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Structural Connectivity: FA
DMN FA
|
0.000 score on a scale
Standard Deviation 0.007
|
-0.003 score on a scale
Standard Deviation 0.006
|
-0.002 score on a scale
Standard Deviation 0.008
|
0.000 score on a scale
Standard Deviation 0.008
|
|
Change in Structural Connectivity: FA
SN FA
|
0.003 score on a scale
Standard Deviation 0.009
|
-0.002 score on a scale
Standard Deviation 0.011
|
-0.002 score on a scale
Standard Deviation 0.009
|
0.001 score on a scale
Standard Deviation 0.011
|
SECONDARY outcome
Timeframe: Baseline, post tDCS (week 3)Population: Modified intention-to-treat sample (participants completing intervention)
Mean diffusivity (MD), axial diffusivity (AxD), and radial diffusivity (RaD) are assessed on diffusion weighted imaging. MD, AxD, RaD values are averaged in default mode network (DMN) and salience network (SN) regions of interest. MD, AxD, and RaD measure water diffusion and are expressed in mm\^2/s (starting from 0 with no maximum value; scaled at x10\^-3). Higher values denote higher diffusion and lower connectivity. Negative changes at post tDCS compared to baseline represent an improvement in the measure.
Outcome measures
| Measure |
AD: Anodal tDCS of the DMN
n=10 Participants
AD: anodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=10 Participants
AD: cathodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=9 Participants
bvFTD: anodal tDCS of the salience network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=7 Participants
bvFTD: cathodal tDCS of the default mode network with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Change in Structural Connectivity: MD, AxD, RaD
DMN MD
|
-0.003 x10^-3 mm^2/s
Standard Deviation 0.017
|
-0.001 x10^-3 mm^2/s
Standard Deviation 0.019
|
0.007 x10^-3 mm^2/s
Standard Deviation 0.008
|
0.007 x10^-3 mm^2/s
Standard Deviation 0.008
|
|
Change in Structural Connectivity: MD, AxD, RaD
SN MD
|
-0.004 x10^-3 mm^2/s
Standard Deviation 0.016
|
-0.002 x10^-3 mm^2/s
Standard Deviation 0.017
|
0.010 x10^-3 mm^2/s
Standard Deviation 0.009
|
0.007 x10^-3 mm^2/s
Standard Deviation 0.008
|
|
Change in Structural Connectivity: MD, AxD, RaD
DMN AxD
|
-0.004 x10^-3 mm^2/s
Standard Deviation 0.017
|
-0.006 x10^-3 mm^2/s
Standard Deviation 0.024
|
0.009 x10^-3 mm^2/s
Standard Deviation 0.014
|
0.008 x10^-3 mm^2/s
Standard Deviation 0.011
|
|
Change in Structural Connectivity: MD, AxD, RaD
SN AxD
|
-0.004 x10^-3 mm^2/s
Standard Deviation 0.017
|
-0.008 x10^-3 mm^2/s
Standard Deviation 0.029
|
0.014 x10^-3 mm^2/s
Standard Deviation 0.018
|
0.010 x10^-3 mm^2/s
Standard Deviation 0.012
|
|
Change in Structural Connectivity: MD, AxD, RaD
DMN RaD
|
-0.002 x10^-3 mm^2/s
Standard Deviation 0.017
|
0.001 x10^-3 mm^2/s
Standard Deviation 0.017
|
0.007 x10^-3 mm^2/s
Standard Deviation 0.009
|
0.006 x10^-3 mm^2/s
Standard Deviation 0.009
|
|
Change in Structural Connectivity: MD, AxD, RaD
SN RaD
|
-0.005 x10^-3 mm^2/s
Standard Deviation 0.017
|
0.000 x10^-3 mm^2/s
Standard Deviation 0.015
|
0.008 x10^-3 mm^2/s
Standard Deviation 0.009
|
0.005 x10^-3 mm^2/s
Standard Deviation 0.011
|
Adverse Events
AD: Anodal tDCS of the DMN
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AD: Cathodal tDCS of the SN
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
bvFTD: Anodal tDCS of the SN
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
bvFTD: Cathodal tDCS of the DMN
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AD: Anodal tDCS of the DMN
n=11 participants at risk
AD: anodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=11 participants at risk
AD: cathodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=12 participants at risk
bvFTD: anodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=11 participants at risk
bvFTD: cathodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal infarct
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
Other adverse events
| Measure |
AD: Anodal tDCS of the DMN
n=11 participants at risk
AD: anodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
AD: Cathodal tDCS of the SN
n=11 participants at risk
AD: cathodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Anodal tDCS of the SN
n=12 participants at risk
bvFTD: anodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: prefrontal cortex
|
bvFTD: Cathodal tDCS of the DMN
n=11 participants at risk
bvFTD: cathodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks.
Stimulation target: inferior parietal cortex
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 2 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
General disorders
Chest pain
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Skin and subcutaneous tissue disorders
Itching (tDCS related discomfort sensation)
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
27.3%
3/11 • Number of events 4 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Skin and subcutaneous tissue disorders
Pain (tDCS related discomfort sensation)
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Skin and subcutaneous tissue disorders
Burning (tDCS related discomfort sensation)
|
18.2%
2/11 • Number of events 2 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 2 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
18.2%
2/11 • Number of events 2 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Skin and subcutaneous tissue disorders
Warmth/Heat (tDCS related discomfort sensation)
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Skin and subcutaneous tissue disorders
Pinching (tDCS related discomfort sensation)
|
45.5%
5/11 • Number of events 5 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
45.5%
5/11 • Number of events 7 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
25.0%
3/12 • Number of events 3 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Skin and subcutaneous tissue disorders
Metallic/Iron taste (tDCS related discomfort sensation)
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Skin and subcutaneous tissue disorders
Fatigue (tDCS related discomfort sensations)
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
|
Skin and subcutaneous tissue disorders
Other tDCS related discomfort sensations
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
9.1%
1/11 • Number of events 1 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/12 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
0.00%
0/11 • Adverse events were monitored from the time of enrollment to follow-up assessment (approx 6 months).
A questionnaire was administered to all participants to monitor events occurring within 24 hours after each tDCS session. A questionnaire was also administered at the end of the first and last tDCS sessions to monitor the occurrence of the most common discomfort sensations related to tDCS and their intensity.
|
Additional Information
Michela Pievani
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Phone: +39 030 35011
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place