Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    125
  • sponsor
    VA Office of Research and Development
Updated on 25 January 2021
dementia
antidepressants
transcranial magnetic stimulation
mini-mental state examination
memory impairment

Summary

Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild memory problems. Their motivation, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the front part of their brain over 20 sessions. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.

Description

Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild cognitive impairment. Their motivation, other behavioral problems, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the dorsolateral prefrontal cortex over 20 daily sessions on consecutive week days. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.

Details
Condition Transcranial magnetic stimulation, Apathy, Mild Cognitive Impairment, Mild Neurocognitive Disorder
Treatment transcranial magnetic stimulation
Clinical Study IdentifierNCT03590327
SponsorVA Office of Research and Development
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 55 yrs?
Gender: Male or Female
Do you have any of these conditions: Apathy or Transcranial magnetic stimulation or Mild Cognitive Impairment?
Do you have any of these conditions: Apathy or Transcranial magnetic stimulation or Mild Neurocognitive Disorder or Mild Cognitive Impairment?
meeting the modified Mayo Clinic criteria for MCI
Having caregivers
apathy threshold (NPI)
MMSE 23
On stable dose of antidepressants for at least a month (if applicable)

Exclusion Criteria

PHASE I
Uncontrolled diabetes mellitus (Fasting BS>200mg/dl, HbA1c>10)
Renal disease requiring dialysis
Uncontrolled blood pressure (>160/100, <100 systolic)
Metastatic cancer or undergoing chemotherapy
Deep venous thrombosis or myocardial infarction in past 3 months
Uncontrolled malignant cardiac arrhythmia
Cerebral aneurysm or intracranial bleed in past year
Unstable angina in past month
Unstable abdominal or thoracic aortic aneurysm (>4cm)
End-stage congestive heart failure
EXCLUSIONARY DUE TO rTMS: ALL PHASE II AND SUBSET OF PHASE I THAT RECEIVE
SINGLE SESSION rTMS
Taking medications known to increase risk of seizures from 2012 Beers criteria such as bupropion, chlorpromazine, clozapine
Taking other medications known to increase risk of seizures such as tricyclic antidepressants
Taking ototoxic medications: Aminoglycosides, Cisplatin
History of seizures/ seizures in first degree relatives
Those with implanted device
History of stroke, aneurysm, or cranial neurosurgery
History of bipolar disorder
Current alcohol related disorder needing medical treatment
History of Tourette's syndrome or presence of motor tics
History of abnormal electroencephalogram (EEG)
EXCLUSIONARY DUE TO CONFOUNDING WITH APATHY: PHASE II
Current episode of Major Depressive Disorder
Current use of stimulants
Change in dose of dementia medications within 30 days
Change in dose of antidepressants within 30 days
Clear my responses

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