Clinical trial NCT02621424: Repetitive Transcranial Magnetic Stimulation for Dementia
Official title: Repetitive Transcranial Magnetic Stimulation for Dementia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Keywords: dementia
Mild Cognitive Impairment (MCI)
RTMS
CVLT
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-12-03
Enrollment: 32
Sex: ALL
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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

Primary outcomes:
measure: Changes From Baseline CVLT Scores After Treatment and 4 Month Later
timeFrame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Secondary outcomes:
measure: Changes in Boston Naming After Treatment
timeFrame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
measure: Changes in Plasma BDNF Levels After Treatment
timeFrame: within a week following the last treatment session and 4 months later
measure: Changes in Animal Fluency After Treatment and 4 Months Later
timeFrame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
measure: Changes in Trail Making B Test Score After Treatment and 4 Months Later
timeFrame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
measure: Brief Visual Memory Test (BVMT)
timeFrame: assessed at baseline, end of treatment and 4-month post-treatment follow up
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Jauhtai J Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.