N/A
N=32
Repetitive Transcranial Magnetic Stimulation for Dementia
Dementia · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02621424 ↗Enrolled (actual)
32
Serious AEs
9.4%
Results posted
May 2020
Primary outcome: Primary: Changes From Baseline CVLT Scores After Treatment and 4 Month Later — 8.5; 9.4; 8.6; 8.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RTMS (Device); sham (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline CVLT Scores After Treatment and 4 Month Later |
8.5; 9.4; 8.6; 8.3; 10.1; 9.2 | — |
| SECONDARY Changes in Boston Naming After Treatment |
52.7; 53.7; 52.8; 56.5; 54.4; 55.0 | — |
| SECONDARY Changes in Plasma BDNF Levels After Treatment |
5089; 5054; 5229; 5350 | — |
| SECONDARY Changes in Animal Fluency After Treatment and 4 Months Later |
17.8; 15.8; 15.6; 16.8; 15.8; 16.9 | — |
| SECONDARY Changes in Trail Making B Test Score After Treatment and 4 Months Later |
187.5; 172.8; 179.8; 150.4; 185.8; 197.6 | — |
| SECONDARY Brief Visual Memory Test (BVMT) |
18.9; 17.4; 19.4; 17.2; 18.8; 16.6 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
22.4; 24.3; 22.0; 24.1; 24.8; 24.7 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02621424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.