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Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment (TAMCI)

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ClinicalTrials.gov Identifier: NCT03590327
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 15, 2020
Sponsor:
Collaborators:
Central Arkansas Veterans Healthcare System
University of Arkansas
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE July 18, 2018
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
Change in Apathy Evaluation Scale Score [ Time Frame: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months ]
Range 18-72 Lower score is improvement
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
  • Change in Modified Mini Mental State Examination Score [ Time Frame: 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 [ Time Frame: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months ]
    Range 0-100% Higher score is improvement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
Official Title  ICMJE Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Apathy
  • Mild Cognitive Impairment
  • Transcranial Magnetic Stimulation
Intervention  ICMJE Device: Transcranial Magnetic Stimulation
rTMS
Study Arms  ICMJE
  • No Intervention: Apathy +, rTMS -
    This arm will be followed without intervention
  • Active Comparator: rTMS
    This group will be randomized to receive rTMS treatment
    Intervention: Device: Transcranial Magnetic Stimulation
  • Sham Comparator: Sham
    This group will be randomized to receive sham treatment
    Intervention: Device: Transcranial Magnetic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2018)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Prasad R Padala, MBBS (501) 257-2537 Prasad.Padala@va.gov
Contact: Christopher M Parkes, BS (501) 257-2504 christopher.parkes@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03590327
Other Study ID Numbers  ICMJE D2638-R
1115904 ( Other Identifier: Central Arkansas Veterans Healthcare System )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE
  • Central Arkansas Veterans Healthcare System
  • University of Arkansas
Investigators  ICMJE
Principal Investigator: Prasad R. Padala, MBBS Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
PRS Account VA Office of Research and Development
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP