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Transcranial Magnetic Stimulation for Apathy in MCI

Recruiting

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.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years N/A All Yes
November 1, 2018
December 31, 2022
125

  • 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)

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 3 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

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 2-year period. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not.

Name City State Zip Status Primary Contact
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center
North Little Rock Arkansas 72114-1706 Recruiting Prasad R. Padala
501-257-2537
Prasad.Padala@va.gov

VA Office of Research and Development

  • Central Arkansas Veterans Healthcare System
  • University of Arkansas

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

NCT03590327

Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment