Using magnetic stimulation to treat apathy in older Veterans with mild cognitive impairment
Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
This study is testing whether magnetic stimulation can help older Veterans with mild cognitive impairment feel more motivated and improve their daily functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (North Little Rock, Arkansas) |
| Trial ID | NCT03590327 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial magnetic stimulation (TMS) on apathy in older Veterans diagnosed with mild cognitive impairment. It involves a three-phase approach with 125 participants, where eligible Veterans will receive either real or sham TMS over 20 sessions. The study aims to measure changes in motivation, memory, and overall function, while also utilizing genetic testing and biomarkers to identify responders to the treatment. Additionally, the impact on quality of life and progression to dementia will be assessed.
Who should consider this trial
Good fit: Ideal candidates are older Veterans with mild cognitive impairment who exhibit symptoms of apathy and have caregivers.
Not a fit: Patients with uncontrolled diabetes, severe renal disease, or recent history of significant cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve motivation and cognitive function in older Veterans, potentially delaying the progression to dementia.
How similar studies have performed: Previous studies have shown promising results with TMS in treating cognitive and motivational deficits, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
North Little Rock, Arkansas
- Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR — North Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Prasad R. Padala, MBBS MBBS — Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
- Study coordinator: Prasad R Padala, MBBS MBBS
- Email: Prasad.Padala@va.gov
- Phone: (501) 257-2537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.