Repetitive Transcranial Magnetic Stimulation for Dementia (rTMS for demen)
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| ClinicalTrials.gov Identifier: NCT02621424 |
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Recruitment Status :
Active, not recruiting
First Posted : December 3, 2015
Results First Posted : May 27, 2020
Last Update Posted : November 4, 2022
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Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dementia Mild Cognitive Impairment | Device: RTMS Device: sham | Not Applicable |
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:
- 1: rTMS- will lead to higher performance on secondary cognitive measures relating to executive function and naming compared to performance by participants in the sham treatment group at the termination of treatment; and that
- 2: rTMS-induced memory improvement parallels changes in serum and cerebrospinal fluid (CSF) brain-derived neurotrophic factor (BDNF) levels after treatment.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 32 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Repetitive Transcranial Magnetic Stimulation for Dementia |
| Actual Study Start Date : | January 1, 2016 |
| Actual Primary Completion Date : | February 28, 2019 |
| Estimated Study Completion Date : | October 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: RTMS
repetitive transcranial magnetic stimulation
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Device: RTMS
stimulation of the brain with magnetic pulses |
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Sham Comparator: sham
sham noise to block the sound of treatment
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Device: sham
sham noise to block the sound of stimulation |
Primary Outcome Measures :
- Changes From Baseline CVLT Scores After Treatment and 4 Month Later [ Time Frame: Assessed at baseline, end of treatment, and 4-month post-treatment 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).
Secondary Outcome Measures :
- Changes in Boston Naming After Treatment [ Time Frame: Assessed at baseline, end of treatment, and 4-month post-treatment 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).
- Changes in Plasma BDNF Levels After Treatment [ Time Frame: within a week following the last treatment session and 4 months later ]
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).
- Changes in Animal Fluency After Treatment and 4 Months Later [ Time Frame: Assessed at baseline, end of treatment, and 4-month post-treatment 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).
- Changes in Trail Making B Test Score After Treatment and 4 Months Later [ Time Frame: Assessed at baseline, end of treatment, and 4-month post-treatment 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.
- Brief Visual Memory Test (BVMT) [ Time Frame: assessed at baseline, end of treatment and 4-month post-treatment 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.
- Montreal Cognitive Assessment (MoCA) [ Time Frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up ]
MoCA is a one page, 30 point cognitive screening test. It test the following cognitive domains:
- short-term memory (5 points)- two learning trials of five nouns and delayed recall after approximately five minutes.
- visuospatial abilities - clock-drawing task (3 points) and copy a cube (1 point).
- executive functions - alternation task abbreviated trail-making B (1 point), and a two-item verbal abstraction task (2 points).
- 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).
- language - three-item confrontation naming (3 points), repetition of two sentences (2 points), and verbal fluency (1 point).
- abstract reasoning - describe the similarity of tasks (2 points).
- orientation to time and place (6 points). Minimum score: 0. Maximum score: 30. Higher the better.
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| Ages Eligible for Study: | 55 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Veterans aged 55 years or older
- Diagnosed with Mild Cognitive Impairment (MCI) or dementia likely due to Alzheimer's disease.
- Ability to obtain a Motor Threshold, determined during the screening process.
- With an adequately stable condition and living environment to enable attendance at scheduled clinic visits.
- If on a prescription medication for cognition that medication dose will be stable for at least 4 weeks prior to randomization into the study and participant will be willing to remain on a stable regimen during the acute treatment phase.
- Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form to be signed by the participant, or a designated legal representative when the participant lacks decision making capacity prior to participating in any study- specific procedures or assessments.
Exclusion Criteria:
- Patients with prior exposure to rTMS or electroconvulsive therapy (ECT).
- Unable to safely withdraw, at least two weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures.
- Have a cardiac pacemaker or a cochlear implant.
- Have an implanted device deep brain stimulation or metal in the brain
- Current substance abuse not including caffeine or nicotine as determined by patient report or chart review.
- Active current suicidal intent or plan as determined by patient report or chart review.
- Current or Prior history of a seizure disorder as determined by patient report or chart review
- Traumatic brain injury within the last two months
- Participation in another concurrent interventional clinical trial
- Known current psychosis as determined by patient report or chart review.
- Current or prior history of a mass lesion, cerebral infarct or other non-cognitive, active central nervous system (CNS) disease that would increase the risk for seizure.
- Not fluent in English or a hearing impairment severe enough to impair comprehension
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621424
Locations
| United States, California | |
| VA Palo Alto Health Care System, Palo Alto, CA | |
| Palo Alto, California, United States, 94304-1290 | |
Sponsors and Collaborators
VA Office of Research and Development
Investigators
| Principal Investigator: | Jauhtai J Cheng, MD | VA Palo Alto Health Care System, Palo Alto, CA |
Study Documents (Full-Text)
Documents provided by VA Office of Research and Development:
Documents provided by VA Office of Research and Development:
Study Protocol [PDF] January 31, 2020
Statistical Analysis Plan [PDF] January 31, 2020
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT02621424 |
| Other Study ID Numbers: |
E1889-P RX14-009 ( Other Grant/Funding Number: VA ) |
| First Posted: | December 3, 2015 Key Record Dates |
| Results First Posted: | May 27, 2020 |
| Last Update Posted: | November 4, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by VA Office of Research and Development:
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dementia Mild Cognitive Impairment (MCI) RTMS CVLT |
Additional relevant MeSH terms:
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Dementia Cognitive Dysfunction Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |