Trial Outcomes & Findings for tDCS and Cognitive Efficiency in Ageing (NCT NCT05216315)
NCT ID: NCT05216315
Last Updated: 2024-12-19
Results Overview
This test presents a list of 16 words that, after being read by the evaluator, have to be repeated by the participant. The list is repeated five times (trials); the participant is again asked to remember the 16 words. The test was administered to evaluate the participant's immediate memory (Trial 1), learning ability (Trial 5 ). Post-intervention minus baseline. Scale is scored 0-16. Difference score range is (-16 to 16) with positive scores reflecting improvement.
COMPLETED
NA
38 participants
Baseline to approximately 4 weeks
2024-12-19
Participant Flow
Participant milestones
| Measure |
tDCS. Transcranial Direct Current Stimulation
The stimulation time was 20 minutes, with an initial and final ramp of 30 seconds so that the participant could adapt to the sensation of the current. 10 sesions. Constant current intensity of 2 mA The anode was placed on position F3, coinciding with the dorsolateral prefrontal cortex, and the cathode was placed on Fp2, coinciding with the right supraorbital area (rSO).
Transcranial direct current stimulation (tDCS): 10 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus HDC stimulator (Newronika TM)
|
Sham Stimulation
The sham group received direct current only on the ramps to generate a sensation of the effect.
Sham stimulation: The sham group received direct current only on the ramps to generate a sensation of the effect.10 sessions
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
tDCS and Cognitive Efficiency in Ageing
Baseline characteristics by cohort
| Measure |
tDCS. Transcranial Direct Current Stimulation
n=17 Participants
The stimulation time was 20 minutes, with an initial and final ramp of 30 seconds so that the participant could adapt to the sensation of the current. 10 sesions. Constant current intensity of 2 mA The anode was placed on position F3, coinciding with the dorsolateral prefrontal cortex, and the cathode was placed on Fp2, coinciding with the right supraorbital area (rSO).
Transcranial direct current stimulation (tDCS): 10 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus HDC stimulator (Newronika TM)
|
Sham Stimulation
n=16 Participants
The sham group received direct current only on the ramps to generate a sensation of the effect.
Sham stimulation: The sham group received direct current only on the ramps to generate a sensation of the effect.10 sessions
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
76.6 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
73.4 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
75 years
STANDARD_DEVIATION 6.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to approximately 4 weeksThis test presents a list of 16 words that, after being read by the evaluator, have to be repeated by the participant. The list is repeated five times (trials); the participant is again asked to remember the 16 words. The test was administered to evaluate the participant's immediate memory (Trial 1), learning ability (Trial 5 ). Post-intervention minus baseline. Scale is scored 0-16. Difference score range is (-16 to 16) with positive scores reflecting improvement.
Outcome measures
| Measure |
tDCS. Transcranial Direct Current Stimulation
n=17 Participants
The stimulation time was 20 minutes, with an initial and final ramp of 30 seconds so that the participant could adapt to the sensation of the current. 10 sesions. Constant current intensity of 2 mA The anode was placed on position F7, coinciding with the dorsolateral prefrontal cortex, and the cathode was placed on Fp2, coinciding with the right supraorbital area (rSO).
Transcranial direct current stimulation (tDCS): 10 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus HDC stimulator (Newronika TM)
|
Sham Stimulation
n=16 Participants
The sham group received direct current only on the ramps to generate a sensation of the effect.
Sham stimulation: The sham group received direct current only on the ramps to generate a sensation of the effect.10 sessions
|
|---|---|---|
|
Complutense Verbal Learning Test (TAVEC) - Memory
Trial 1
|
0.94 units on a scale
Standard Deviation 0.35
|
-0.81 units on a scale
Standard Deviation 0.03
|
|
Complutense Verbal Learning Test (TAVEC) - Memory
Trial 5
|
1.65 units on a scale
Standard Deviation 0.5
|
-0.31 units on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Baseline to approximately 4 weeksDirect and inverse digits of the Wechsler Intelligence Scale for Adults-III (Wechsler, 2001). These tests assess attentional capacity by exposing the participant to increasing amounts of information. On the direct digits task, which is used to assess immediate recall, the subject must repeat the sequence of numbers in the same order in which they are read by the examiner. On the inverse digit task, which assesses working memory and mental flexibility, the subject must say the digits backwards from the way they were presented by the examiner. Both tests are evaluated in the same way, assigning one point for each correct item, with a maximum score of 16 for both tests. Post-intervention minus baseline. Difference score range is (-16 to 16) with positive scores reflecting improvement.
Outcome measures
| Measure |
tDCS. Transcranial Direct Current Stimulation
n=17 Participants
The stimulation time was 20 minutes, with an initial and final ramp of 30 seconds so that the participant could adapt to the sensation of the current. 10 sesions. Constant current intensity of 2 mA The anode was placed on position F7, coinciding with the dorsolateral prefrontal cortex, and the cathode was placed on Fp2, coinciding with the right supraorbital area (rSO).
Transcranial direct current stimulation (tDCS): 10 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus HDC stimulator (Newronika TM)
|
Sham Stimulation
n=16 Participants
The sham group received direct current only on the ramps to generate a sensation of the effect.
Sham stimulation: The sham group received direct current only on the ramps to generate a sensation of the effect.10 sessions
|
|---|---|---|
|
Digits Wechsler Intelligence Scale for Adults-III (WAIS-III)
Direct Digits
|
1.35 units on a scale
Standard Deviation 0.62
|
-0.18 units on a scale
Standard Deviation 0.84
|
|
Digits Wechsler Intelligence Scale for Adults-III (WAIS-III)
Inverse digits
|
0.17 units on a scale
Standard Deviation 1.15
|
-0.43 units on a scale
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: Baseline to approximately 4 weeksThis is a screening test for general cognitive status. This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient. Post-intervention minus baseline. Scale is scored 0-30. Difference score range is (-30 to 30) with positive scores reflecting improvement.
Outcome measures
| Measure |
tDCS. Transcranial Direct Current Stimulation
n=17 Participants
The stimulation time was 20 minutes, with an initial and final ramp of 30 seconds so that the participant could adapt to the sensation of the current. 10 sesions. Constant current intensity of 2 mA The anode was placed on position F7, coinciding with the dorsolateral prefrontal cortex, and the cathode was placed on Fp2, coinciding with the right supraorbital area (rSO).
Transcranial direct current stimulation (tDCS): 10 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus HDC stimulator (Newronika TM)
|
Sham Stimulation
n=16 Participants
The sham group received direct current only on the ramps to generate a sensation of the effect.
Sham stimulation: The sham group received direct current only on the ramps to generate a sensation of the effect.10 sessions
|
|---|---|---|
|
Mini Mental State Examination
|
2.18 score on a scale
Standard Deviation 0.03
|
-0.44 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksBarcelona Test assesses the ability to access and recall lexical and semantic items by means of two subtests: a. Semantic fluency: recall the highest number of words from the category 'animals' in one minute; b. Phonological fluency: recall the highest number of words beginning with the letter 'p' in three minutes. Minimum and maximum range for Semantic fluency and Phonological fluency: 0 to n (no upper limit). Method of calculation: Scores for each subtest are reported separately. No combined scores or averages between subtests are calculated. Interpretation: Good categorical recall is considered good when evoking more than 16 animals in 1 minute and good verbal fluency when evoking more than 19 words beginning with 'p' in 3 minutes. This test assesses the ability to access and recall items from the lexical and semantic store. Processes involved: processing speed, cognitive flexibility and working memory. Post-intervention less baseline with positive scores reflecting improvement.
Outcome measures
| Measure |
tDCS. Transcranial Direct Current Stimulation
n=17 Participants
The stimulation time was 20 minutes, with an initial and final ramp of 30 seconds so that the participant could adapt to the sensation of the current. 10 sesions. Constant current intensity of 2 mA The anode was placed on position F7, coinciding with the dorsolateral prefrontal cortex, and the cathode was placed on Fp2, coinciding with the right supraorbital area (rSO).
Transcranial direct current stimulation (tDCS): 10 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus HDC stimulator (Newronika TM)
|
Sham Stimulation
n=16 Participants
The sham group received direct current only on the ramps to generate a sensation of the effect.
Sham stimulation: The sham group received direct current only on the ramps to generate a sensation of the effect.10 sessions
|
|---|---|---|
|
Barcelona Test (BT) - Ability to Access and Recall Elements From the Lexical and Semantic Store
Semantic fluency
|
0.47 Number of words evoked
Standard Deviation 4.47
|
-5.72 Number of words evoked
Standard Deviation 4.22
|
|
Barcelona Test (BT) - Ability to Access and Recall Elements From the Lexical and Semantic Store
Phonological fluency
|
1.77 Number of words evoked
Standard Deviation 0.1
|
0.69 Number of words evoked
Standard Deviation 0.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to approximately 4 weeksThis test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to approximately 4 weeksThis test offers a rapid and effective screening with excellent discriminative properties for amnestic Mild Cognitive Impairment (MCI-A) and early AD in the general primary care population. The test assesses a variety of abilities such as encoding, orientation, semantic memory and free recall. It consists of oral questions with only one possible answer, and the maximum achievable score is 50 points. The optimal cut-off point for distinguishing amnestic-like mild cognitive impairment from subjective memory complaints is 37 points. The optimal cut-off point for Alzheimer's disease is 31 points. Post-intervention minus baseline. Scale is scored 0-50. Difference score range is (-50 to 50) with positive scores reflecting improvement.
Outcome measures
| Measure |
tDCS. Transcranial Direct Current Stimulation
n=17 Participants
The stimulation time was 20 minutes, with an initial and final ramp of 30 seconds so that the participant could adapt to the sensation of the current. 10 sesions. Constant current intensity of 2 mA The anode was placed on position F7, coinciding with the dorsolateral prefrontal cortex, and the cathode was placed on Fp2, coinciding with the right supraorbital area (rSO).
Transcranial direct current stimulation (tDCS): 10 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus HDC stimulator (Newronika TM)
|
Sham Stimulation
n=18 Participants
The sham group received direct current only on the ramps to generate a sensation of the effect.
Sham stimulation: The sham group received direct current only on the ramps to generate a sensation of the effect.10 sessions
|
|---|---|---|
|
Memory Alteration Test (M@T) - Cognitive Impairment
|
6.06 score on a scale
Standard Deviation 2.19
|
-0.88 score on a scale
Standard Deviation 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to approximately 4 weeksThis experimental task is composed by three lists of words with two conditions: half and entire. The half condition included two lists of 50 words each, formed entirely from the following letters of the Spanish alphabet: a, e, u, b, d, g, j, n, r, and z (list A) or i, o, c, f, h, l, m, p, s, t, v, and y (list B). List C (entire condition) contained 50 words formed from the entire alphabet, with the only criterion being that each word had to contain at least one letter from list A and at least one letter from list B. In the half condition, the recognition estimates for each participant were derived by subtracting the proportion of false alarms on words with the same letters, as in the study list, from the proportion of hits, whereas in the entire condition, the recognition estimates were derived by subtracting the proportion of false alarms on words with all the letters in the alphabet from the proportion of hits as a way to control the response bias of the participants.
Outcome measures
Outcome data not reported
Adverse Events
tDCS. Transcranial Direct Current Stimulation
Sham Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place