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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Apathy Mild Cognitive Impairment Device: Neurostar repetitive transcranial magnetic stimulator Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment:Pilot Study
Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : July 2016
Arms and Interventions
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Arm Intervention/treatment
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.
 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
Sham Comparator: Sham coil treatment
Neurostar repetitive transcranial magnetic stimulator. 10 treatments identical in duration will be administered over a two week period.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Trials making test [ Time Frame: 8 weeks ]
    Widely used test for assessment of executive function.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 91 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190019


Locations
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United States, Arkansas
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
Investigators
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Principal Investigator: Prasad R Padala, MD, MS Central Arkansas Veterans Healthcare System
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prasad R. Padala, Associate Director for Clinical Programs, GRECC, Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT02190019    
Other Study ID Numbers: 391721
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Keywords provided by Prasad R. Padala, Central Arkansas Veterans Healthcare System:
Mild Cognitive Impairment
apathy
executive function
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders