Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation for Dementia (NCT NCT02621424)
NCT ID: NCT02621424
Last Updated: 2025-09-30
Results Overview
Changes of California verbal learning test scores (CVLT) from baseline after treatment and 4 months later. CVLT is 16 points scoring system. (minimum=0, maximum=16, higher the better memory).
COMPLETED
NA
32 participants
Assessed at baseline, end of treatment, and 4-month post-treatment follow up
2025-09-30
Participant Flow
Two hundred and twenty nine patients were screened. 43 patients signed consent. 32 were enrolled.
Thirty two patients were enrolled.
Participant milestones
| Measure |
RTMS
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
18
|
|
Overall Study
COMPLETED
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
RTMS
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Repetitive Transcranial Magnetic Stimulation for Dementia
Baseline characteristics by cohort
| Measure |
RTMS
n=14 Participants
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
n=18 Participants
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
Total
n=32 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
70.8 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
neuropsychological testing
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline, end of treatment, and 4-month post-treatment follow upPopulation: Sham arm: 18 started, 2 withdrew, 3 did not test properly at baseline, 1 did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up. Active arm: 14 started, one withdrew, one did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up.
Changes of California verbal learning test scores (CVLT) from baseline after treatment and 4 months later. CVLT is 16 points scoring system. (minimum=0, maximum=16, higher the better memory).
Outcome measures
| Measure |
RTMS
n=13 Participants
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
n=13 Participants
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
|---|---|---|
|
Changes From Baseline CVLT Scores After Treatment and 4 Month Later
Baseline
|
8.5 score on a scale
Standard Deviation 4.6
|
9.4 score on a scale
Standard Deviation 3.8
|
|
Changes From Baseline CVLT Scores After Treatment and 4 Month Later
End of treatment
|
8.6 score on a scale
Standard Deviation 4.3
|
8.3 score on a scale
Standard Deviation 3.7
|
|
Changes From Baseline CVLT Scores After Treatment and 4 Month Later
4 month follow up
|
10.1 score on a scale
Standard Deviation 4.1
|
9.2 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Assessed at baseline, end of treatment, and 4-month post-treatment follow upPopulation: Sham arm: 18 started, 2 withdrew, 3 did not test properly at baseline, 1 did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up. Active arm: 14 started, one withdrew, one did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up.
Changes in Boston Naming Test (BNT) from baseline was analyzed. BNT is a 60 points scoring system. (minimum=0, maximum=60, higher the better).
Outcome measures
| Measure |
RTMS
n=13 Participants
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
n=13 Participants
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
|---|---|---|
|
Changes in Boston Naming After Treatment
baseline
|
52.7 units on a scale
Standard Deviation 12.4
|
53.7 units on a scale
Standard Deviation 8.3
|
|
Changes in Boston Naming After Treatment
End of treatment
|
52.8 units on a scale
Standard Deviation 13.2
|
56.5 units on a scale
Standard Deviation 3.6
|
|
Changes in Boston Naming After Treatment
4 month followup
|
54.4 units on a scale
Standard Deviation 13.1
|
55.0 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: within a week following the last treatment session and 4 months laterPopulation: Sham arm: 18 started, 13 had baseline BDNF collected, two withdrew. 13 sets of data were available at baseline, 11 sets of data were available at end of treatment. Active arm: 14 started, two did not have BDNF collected. 12 sets of data were available at baseline and at end of treatment.
Changes in BDNF plasma levels (pg/ml) from baseline were analyzed after treatment. BDNF is a plasma biomarker, minimum=0, no maximum. Higher number means more BDNF synthesis).
Outcome measures
| Measure |
RTMS
n=12 Participants
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
n=13 Participants
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
|---|---|---|
|
Changes in Plasma BDNF Levels After Treatment
baseline
|
5089 pg/ml
Standard Deviation 3508
|
5054 pg/ml
Standard Deviation 3440
|
|
Changes in Plasma BDNF Levels After Treatment
post treatment
|
5229 pg/ml
Standard Deviation 3713
|
5350 pg/ml
Standard Deviation 4981
|
SECONDARY outcome
Timeframe: Assessed at baseline, end of treatment, and 4-month post-treatment follow upPopulation: Sham arm: 18 started, 2 withdrew, 3 did not test properly at baseline, 1 did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up. Active arm: 14 started, one withdrew, one did not test properly at end of treatment, one did not show for follow up. 13 sets of data were available at baseline, 12 sets were available at end of treatment, 12 sets were available at follow up.
Animal Fluency (AF) is a scoring system to assess the ability to generate a list of related words. The score is the number of animals the examinee can name in one minute time. (Minimum = 0, No maximum, higher the better).
Outcome measures
| Measure |
RTMS
n=13 Participants
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
n=13 Participants
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
|---|---|---|
|
Changes in Animal Fluency After Treatment and 4 Months Later
baseline
|
17.8 units on a scale
Standard Deviation 6.6
|
15.8 units on a scale
Standard Deviation 3.4
|
|
Changes in Animal Fluency After Treatment and 4 Months Later
end of treatment
|
15.6 units on a scale
Standard Deviation 4.9
|
16.8 units on a scale
Standard Deviation 3.0
|
|
Changes in Animal Fluency After Treatment and 4 Months Later
4 month followup
|
15.8 units on a scale
Standard Deviation 5.4
|
16.9 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Assessed at baseline, end of treatment, and 4-month post-treatment follow upPopulation: Sham arm: 18 started, 2 withdrew, 3 did not test properly at baseline, 1 did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up. Active arm: 14 started, one withdrew, one did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up.
Trail making B is a scoring system for the assessment of the mental flexibility, processing speed and executive function. The score is the time (in seconds) it takes for the examinee to draw line segments connecting sequentially from 1-A-2-B-3....all the way to12-L-13. (The lower score means faster speed and means better performance. The minimum is (hypothetically) zero. There is no maximum. However, in some test centers, the maximum allowed time is 200 seconds.
Outcome measures
| Measure |
RTMS
n=13 Participants
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
n=13 Participants
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
|---|---|---|
|
Changes in Trail Making B Test Score After Treatment and 4 Months Later
4 month followup
|
185.8 Seconds
Standard Deviation 237.8
|
197.6 Seconds
Standard Deviation 204.9
|
|
Changes in Trail Making B Test Score After Treatment and 4 Months Later
baseline
|
187.5 Seconds
Standard Deviation 222.2
|
172.8 Seconds
Standard Deviation 94.8
|
|
Changes in Trail Making B Test Score After Treatment and 4 Months Later
end of treatment
|
179.8 Seconds
Standard Deviation 207.7
|
150.4 Seconds
Standard Deviation 64.9
|
SECONDARY outcome
Timeframe: assessed at baseline, end of treatment and 4-month post-treatment follow upPopulation: Sham arm: 18 started, 2 withdrew, 3 did not test properly at baseline, 1 did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up. Active arm: 14 started, one withdrew, one did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up.
A piece of paper with 6 simple drawings is presented to the subject for 10 seconds. The subject is then asked to draw these drawings from memory. The process is repeated three times to assess visual memory and learning. Each correct drawing scores two pints. Maximum score for three trials is 36. Minimum score is 0. Higher the better.
Outcome measures
| Measure |
RTMS
n=13 Participants
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
n=13 Participants
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
|---|---|---|
|
Brief Visual Memory Test (BVMT)
Baseline
|
18.9 score on a scale
Standard Deviation 9.0
|
17.4 score on a scale
Standard Deviation 6.4
|
|
Brief Visual Memory Test (BVMT)
End of treatment
|
19.4 score on a scale
Standard Deviation 8.7
|
17.2 score on a scale
Standard Deviation 7.3
|
|
Brief Visual Memory Test (BVMT)
4 month follow up
|
18.8 score on a scale
Standard Deviation 7.5
|
16.6 score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Assessed at baseline, end of treatment, and 4-month post-treatment follow upPopulation: Sham arm: 18 started, 2 withdrew, 3 did not test properly at baseline, 1 did not show for follow up. 13 sets of data were available at baseline, 13 sets were available at end of treatment, 12 sets were available at follow up. Active arm: 14 started, one withdrew, two did not test properly at end of treatment, one did not show for follow up. 13 sets of data were available at baseline, 11 sets were available at end of treatment, 12 sets were available at follow up.
MoCA is a one page, 30 point cognitive screening test. It test the following cognitive domains: 1. short-term memory (5 points)- two learning trials of five nouns and delayed recall after approximately five minutes. 2. visuospatial abilities - clock-drawing task (3 points) and copy a cube (1 point). 3. executive functions - alternation task abbreviated trail-making B (1 point), and a two-item verbal abstraction task (2 points). 4. attention, concentration, and working memory - a sustained attention task (target detection using tapping; 1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each). 5. language - three-item confrontation naming (3 points), repetition of two sentences (2 points), and verbal fluency (1 point). 6. abstract reasoning - describe the similarity of tasks (2 points). 7. orientation to time and place (6 points). Minimum score: 0. Maximum score: 30. Higher the better.
Outcome measures
| Measure |
RTMS
n=13 Participants
repetitive transcranial magnetic stimulation
RTMS: stimulation of the brain with magnetic pulses
|
Sham
n=13 Participants
sham noise to block the sound of treatment
sham: sham noise to block the sound of stimulation
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
baseline
|
22.4 score on a scale
Standard Deviation 6.1
|
24.3 score on a scale
Standard Deviation 3.0
|
|
Montreal Cognitive Assessment (MoCA)
end of treatment
|
22.0 score on a scale
Standard Deviation 6.0
|
24.1 score on a scale
Standard Deviation 3.9
|
|
Montreal Cognitive Assessment (MoCA)
4 month follow up
|
24.8 score on a scale
Standard Deviation 6.2
|
24.7 score on a scale
Standard Deviation 4.4
|
Adverse Events
RTMS
Sham
Serious adverse events
| Measure |
RTMS
n=14 participants at risk
repetitive transcranial magnetic stimulation
mild headache and irritation at the site of stimulation were reported and thought to be treatment-related. These event were mild and only lasted a day or two.
There were other reported events and were reviewed with the IRB. They were determined to be not related to RTMS treatment.
|
Sham
n=18 participants at risk
sham noise to block the sound of treatment Low amplitude electrical stimulation was used to simulate the sensation of RTMS. The electrical stimulation to the scalp can cause mild sense of irritation, which only occurs when the stimulation is turned on.
There were other reported events and were reviewed with the IRB. They were determined to be not related to RTMS treatment.
|
|---|---|---|
|
Nervous system disorders
epilepsy
|
7.1%
1/14 • Number of events 1 • 1 year post treartment
|
11.1%
2/18 • Number of events 2 • 1 year post treartment
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place