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| ID | Type | Description | Link |
|---|---|---|---|
| RX14-009 | Other Grant/Funding Number | VA |
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The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves cognitive function in patients with neurodegenerative conditions which may manifest as mild to moderate cognitive impairment and, in late phase, dementia. This study also intends to investigate if the responses to rTMS intervention are either positively or negatively correlated with the initial severity of cognitive impairment.
The primary hypothesis is that rTMS applied to the dorsolateral prefrontal cortex will lead to improved memory, language and executive function compared to patients who receive a sham, control treatment. The improvement is defined as having higher performance on the California Verbal Learning Test (CVLT-II). Secondary Hypotheses are that:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTMS | Experimental | repetitive transcranial magnetic stimulation |
|
| sham | Sham Comparator | sham noise to block the sound of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTMS | Device | stimulation of the brain with magnetic pulses |
| |
| sham |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline CVLT Scores After Treatment and 4 Month Later | 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). | Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Boston Naming After Treatment | Changes in Boston Naming Test (BNT) from baseline was analyzed. BNT is a 60 points scoring system. (minimum=0, maximum=60, higher the better). | Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
| Changes in Plasma BDNF Levels After Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jauhtai J Cheng, MD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34958013 | Derived | Cheng J, Fairchild JK, McNerney MW, Noda A, Ashford JW, Suppes T, Chao SZ, Taylor J, Rosen AC, Durazzo TC, Lazzeroni LC, Yesavage J. Repetitive Transcranial Magnetic Stimulation as a Treatment for Veterans with Cognitive Impairment and Multiple Comorbidities. J Alzheimers Dis. 2022;85(4):1593-1600. doi: 10.3233/JAD-210349. |
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Thirty two patients were enrolled.
Two hundred and twenty nine patients were screened. 43 patients signed consent. 32 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | RTMS | repetitive transcranial magnetic stimulation RTMS: stimulation of the brain with magnetic pulses |
| FG001 | Sham | sham noise to block the sound of treatment sham: sham noise to block the sound of stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | RTMS | repetitive transcranial magnetic stimulation RTMS: stimulation of the brain with magnetic pulses |
| BG001 | Sham | sham noise to block the sound of treatment sham: sham noise to block the sound of stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes From Baseline CVLT Scores After Treatment and 4 Month Later | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
|
1 year post treartment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RTMS | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epilepsy | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jauhtai Cheng, MD, Staff Neurologist | VA Palo Alto | 650-493-5000 | 63617 | jauhtai.cheng2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2020 | Feb 3, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2020 | Feb 11, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2018 | Oct 24, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Device |
sham noise to block the sound of stimulation |
|
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). |
| within a week following the last treatment session and 4 months later |
| Changes in Animal Fluency After Treatment and 4 Months Later | 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). | Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
| Changes in Trail Making B Test Score After Treatment and 4 Months Later | 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. | Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
| Brief Visual Memory Test (BVMT) | 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. | assessed at baseline, end of treatment and 4-month post-treatment follow up |
| Montreal Cognitive Assessment (MoCA) | MoCA is a one page, 30 point cognitive screening test. It test the following cognitive domains:
| Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| neuropsychological testing | Count of Participants | Participants |
|
| OG001 | Sham | sham noise to block the sound of treatment sham: sham noise to block the sound of stimulation |
|
|
| Secondary | Changes in Boston Naming After Treatment | Changes in Boston Naming Test (BNT) from baseline was analyzed. BNT is a 60 points scoring system. (minimum=0, maximum=60, higher the better). | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
|
|
|
| Secondary | Changes in Plasma BDNF Levels After 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). | 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. | Posted | Mean | Standard Deviation | pg/ml | within a week following the last treatment session and 4 months later |
|
|
|
| Secondary | Changes in Animal Fluency After Treatment and 4 Months Later | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
|
|
|
| Secondary | Changes in Trail Making B Test Score After Treatment and 4 Months Later | 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. | 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. | Posted | Mean | Standard Deviation | Seconds | Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
|
|
|
| Secondary | Brief Visual Memory Test (BVMT) | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, end of treatment and 4-month post-treatment follow up |
|
|
|
| Secondary | Montreal Cognitive Assessment (MoCA) | MoCA is a one page, 30 point cognitive screening test. It test the following cognitive domains:
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline, end of treatment, and 4-month post-treatment follow up |
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| 0 |
| 14 |
| 1 |
| 14 |
| 0 |
| 14 |
| EG001 | Sham | 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. | 0 | 18 | 2 | 18 | 0 | 18 |
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| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| End of treatment |
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| 4 month followup |
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| post treatment |
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| end of treatment |
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| end of treatment |
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| 4 month followup |
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| End of treatment |
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| 4 month follow up |
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| end of treatment |
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| 4 month follow up |
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