Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 11/9/2018 |
| Start Date: | November 1, 2018 |
| End Date: | December 31, 2022 |
| Contact: | Prasad R Padala, MBBS |
| Email: | Prasad.Padala@va.gov |
| Phone: | (501) 257-2537 |
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.
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.
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
We found this trial at
1
site
2200 Fort Roots Drive
North Little Rock, Arkansas 72114
North Little Rock, Arkansas 72114
Principal Investigator: Prasad R. Padala, MBBS
Phone: 501-257-2537
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