Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jul 5, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Transcranial Magnetic Stimulation (TMS) to help older Veterans who experience apathy, which is a lack of motivation and initiative, often linked to mild cognitive impairment (MCI). Apathy can worsen health issues, increase dependence on others, and lead to faster progression to dementia. The study aims to find out if TMS can improve motivation, memory, and daily functioning in 125 older Veterans with MCI. Participants will receive either real or sham (placebo) magnetic stimulation over 20 sessions while their progress is monitored. Researchers will also look at genetic factors to see why some people respond to the treatment better than others.

To participate in the study, individuals must meet specific criteria, including having mild memory problems and a certain level of apathy, as well as having a caregiver. They should be stable on antidepressants for at least a month if they take them. Participants can expect to undergo regular assessments of their memory and daily activities throughout the study. The trial is also examining how the COVID-19 pandemic has affected cognitive health and caregiver stress, aiming to develop new ways to support Veterans during these challenging times.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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