North Little Rock, Arkansas 72114


Purpose:

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.


Study 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 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.


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


NCT ID:

NCT03590327


Primary Contact:

Principal Investigator
Prasad R. Padala, MBBS
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Prasad R Padala, MBBS
Phone: (501) 257-2537
Email: Prasad.Padala@va.gov


Backup Contact:

N/A


Location Contact:

North Little Rock, Arkansas 72114
United States

Prasad R Padala, MBBS
Phone: 501-257-2537
Email: Prasad.Padala@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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