TAMCI: Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Apathy +, rTMS - This arm will be followed without intervention |
|
| Active Comparator: rTMS This group will be randomized to receive rTMS treatment |
Device: Transcranial Magnetic Stimulation
rTMS
|
| Sham Comparator: Sham This group will be randomized to receive sham treatment |
Device: Transcranial Magnetic Stimulation
rTMS
|
Outcome Measures
Primary Outcome Measures
- Change in Apathy Evaluation Scale Score [2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months]
Range 18-72 Lower score is improvement
Secondary Outcome Measures
- Change in Modified Mini Mental State Examination Score [2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months]
Range 0-100 Higher score is improvement
- Change in Conner's Continuous Performance Test Commission Error percentage [2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months]
Range 0-100% Higher score is improvement
Eligibility Criteria
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)
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Metastatic cancer or undergoing chemotherapy
-
Deep venous thrombosis or myocardial infarction in past 3 months
-
Uncontrolled malignant cardiac arrhythmia
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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.
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Taking other medications known to increase risk of seizures such as tricyclic antidepressants.
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Taking ototoxic medications: Aminoglycosides, Cisplatin
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History of seizures/ seizures in first degree relatives
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Those with implanted device
-
History of stroke, aneurysm, or cranial neurosurgery
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History of bipolar disorder
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Current alcohol related disorder needing medical treatment
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History of Tourette's syndrome or presence of motor tics
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History of abnormal electroencephalogram (EEG)
EXCLUSIONARY DUE TO CONFOUNDING WITH APATHY: PHASE II
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Current episode of Major Depressive Disorder
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Current use of stimulants
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Change in dose of dementia medications within 30 days
-
Change in dose of antidepressants within 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | North Little Rock | Arkansas | United States | 72114-1706 |
Sponsors and Collaborators
- VA Office of Research and Development
- Central Arkansas Veterans Healthcare System
- University of Arkansas
Investigators
- Principal Investigator: Prasad R. Padala, MBBS, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D2638-R
- 1115904