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Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment:Pilot Study

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ClinicalTrials.gov Identifier: NCT02190019
Recruitment Status : Unknown
Verified February 2016 by Prasad R. Padala, Central Arkansas Veterans Healthcare System.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2014
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Prasad R. Padala, Central Arkansas Veterans Healthcare System

Tracking Information
First Submitted Date  ICMJE July 11, 2014
First Posted Date  ICMJE July 15, 2014
Last Update Posted Date February 10, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
Apathy Evaluation Scale (AES) [ Time Frame: 8 weeks ]
AES is an 18-item scale that assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02190019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
Trials making test [ Time Frame: 8 weeks ]
Widely used test for assessment of executive function.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 14, 2014)
Exit 25 [ Time Frame: 8 weeks ]
EXIT-25 is a bedside measure of executive function. It defines the behavioral sequelae of executive dyscontrol and provides a standardized clinical encounter in which they can be observed.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment:Pilot Study
Official Title  ICMJE Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment:Pilot Study
Brief Summary Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients with apathy, rTMS to the frontal lobe might be helpful in treating the same. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and executive function better than sham treatment in those with MCI
Detailed Description

Objective: Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients with apathy, rTMS to the frontal lobe might be helpful in treating the same.

Specific Aims:

  • To determine the efficacy of rTMS to the dorsolateral prefrontal cortex (DLPFC) in treating apathy in MCI in comparison to sham treatment.
  • To compare the efficacy of rTMS to the DLPFC on executive function in MCI in comparison to sham treatment.

Research Plan: Current study is a randomized sham controlled cross-over study of daily rTMS.

Methods: 20 subjects with MCI and apathy will be enrolled to randomize 8 to a total of 20 sessions of treatment (2 weeks sham, 2 weeks rTMS, with 4 weeks of washout period). Subjects will be randomly assigned to rTMS or sham treatment after consent. After 2 weeks of treatment there will be a 4 week period with no treatment. At the end of the 4-week wash out period, subjects will be crossed over to the next treatment arm (i.e. those who received rTMS in the beginning will receive sham treatment and vice versa). Subjects will be followed for four additional weeks after treatment. Apathy will be assessed using the Apathy Evaluation Scale. Memory, executive function, functional status and caregiver burden will be assessed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Apathy
  • Mild Cognitive Impairment
Intervention  ICMJE Device: Neurostar repetitive transcranial magnetic stimulator
The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period.
Other Name: rTMS
Study Arms  ICMJE
  • Active Comparator: transcranial magnetic stimulator
    Neurostar repetitive transcranial magnetic stimulator. The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period.
    Intervention: Device: Neurostar repetitive transcranial magnetic stimulator
  • Sham Comparator: Sham coil treatment
    Neurostar repetitive transcranial magnetic stimulator. 10 treatments identical in duration will be administered over a two week period.
    Intervention: Device: Neurostar repetitive transcranial magnetic stimulator
Publications * Padala PR, Padala KP, Lensing SY, Jackson AN, Hunter CR, Parkes CM, Dennis RA, Bopp MM, Caceda R, Mennemeier MS, Roberson PK, Sullivan DH. Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study. Psychiatry Res. 2018 Mar;261:312-318. doi: 10.1016/j.psychres.2017.12.063. Epub 2018 Jan 5.

*   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 Unknown status
Actual Enrollment  ICMJE
 (submitted: February 9, 2016)
14
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2014)
20
Estimated Study Completion Date  ICMJE July 2016
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects age ≥ 55 years,
  2. Subjects meeting Petersen's criteria for MCI,
  3. Apathy Evaluation Scale-Clinician (AES-C) score of ≥ 30,
  4. Mini Mentla Status Examination (MMSE) ≥ 23,
  5. Subjects who clear the TMS adult safety scale (TASS)
  6. On stable dose of antidepressants (if applicable) for at least two months

Exclusion Criteria:

  1. Subjects taking medications known to increase the risk of seizures from the 2012 Beers criteria: Bupropion, chlorpromazine, clozapine, maprotiline, olanzapine, thioridazine, thiothixene, and tramadol.
  2. Subjects taking medications known to increase seizure threshold not listed in the Beers criteria but in the opinion of PI increase seizure threshold: tricyclic antidepressants, theophylline, methylphenidate, and high-dose thyroid supplementation.
  3. Subjects taking ototoxic medications: Aminoglycosides, Cisplatin.
  4. Subjects in current episode of major depression
  5. History of bipolar disorder
  6. Subjects with history of seizure or first degree relative with seizure disorder
  7. Subjects with implanted device: wearable or implantable cardioverter defibrillators, conductive, ferromagnetic, or other magnetic sensitive metals that are implanted or are non-removable within 30 cm of the treatment coil or those with cochlear implants
  8. Subjects with diagnosis of current alcohol related problems
  9. Subjects with history of stroke , aneurysm, or cranial neurosurgery
  10. Any condition that in the opinion of the study physician is likely to compromise their ability to safely participate in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 91 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02190019
Other Study ID Numbers  ICMJE 391721
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prasad R. Padala, Central Arkansas Veterans Healthcare System
Study Sponsor  ICMJE Central Arkansas Veterans Healthcare System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prasad R Padala, MD, MS Central Arkansas Veterans Healthcare System
PRS Account Central Arkansas Veterans Healthcare System
Verification Date February 2016

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