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Transcranial Magnetic Stimulation for Apathy in MCI
Start: November 1, 2018
End: September 2023
Enrollment: 125
What Is This Study About?
In this multi-phase study, researchers are investigating the effects of transcranial magnetic stimulation (TMS) on motivation, memory, and function in older veterans with mild memory problems. TMS is a noninvasive procedure that involves the use of magnetic fields to stimulate areas of the brain. Participants will undergo either real or sham magnetic stimulation to the front part of their brain over 20 sessions. Researchers will measure changes in function, qualify of life, and rates of progression to dementia over a two-year period. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not.
Do I Qualify To Participate in This Study?
Minimum Age: 55 Years
Maximum Age: N/A
Must have:
- Meet the modified Mayo Clinic criteria for mild cognitive impairment (MCI)
- Have caregiver
- Meet the apathy threshold on the Neuropsychiatric Inventory
- Mini-Mental State Examination score of 23 (mild dementia)
- On stable dose of antidepressants for at least a month (if applicable)
Must NOT have:
Phase I Participants
- Uncontrolled diabetes mellitus (fasting blood sugar greater than 200 mg/dl, HbA1c greater than 10)
- Kidney disease requiring dialysis
- Uncontrolled blood pressure (greater than 160/100 mmHg or less than 100 systolic)
- Metastatic cancer or undergoing chemotherapy
- Deep venous thrombosis or heart attack in past three months
- Uncontrolled malignant heart arrhythmia
- Cerebral aneurysm or intracranial bleed in past year
- Unstable angina in past month
- Unstable abdominal or thoracic aortic aneurysm (greater than 4 cm)
- End-stage congestive heart failure
Phase II Participants and Subset of Phase I Participants Receiving Repetitive TMS
- Taking medications known to increase risk of seizures, such as bupropion (antidepressant), chlorpromazine (antipsychotic), clozapine (antipsychotic), or tricyclic antidepressants
- Taking ototoxic medications, including aminoglycosides (a class of antibiotics) and cisplatin (chemotherapy drug)
- History of seizures or seizures in first-degree relatives
- Implanted devices
- History of stroke, aneurysm, or cranial neurosurgery
- History of bipolar disorder
- Current alcohol-related disorder needing medical treatment
- History of Tourette syndrome or presence of motor tics
- History of abnormal electroencephalogram
Phase II Participants
- Current episode of major depressive disorder
- Current use of stimulants
- Change in dose of dementia medications in past 30 days
- Change in dose of antidepressants in past 30 days
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
| Arkansas | |
|---|---|
|
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, AR 72114-1706
Recruiting
Richard R Owen, MD |
|
Who Sponsors This Study?
Lead: VA Office of Research and Development
Collaborator Sponsor
- Central Arkansas Veterans Healthcare System
- University of Arkansas
Source: ClinicalTrials.gov ID: NCT03590327
An official website of the U.S. government, managed by the National Institutes on Aging at the National Institutes of Health