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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Apathy, Mild Cognitive Impairment

In brief

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

Key facts

Study ID

NCT02190019

Run by

Central Arkansas Veterans Healthcare System

People needed

14

Starts

2014-04-01

Expected to finish

2016-07-01

Last updated by the study team

2016-02-10

Who can join

Age: 55 and older, up to 91. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subjects taking medications known to increase the risk of seizures from the 2012 Beers criteria: Bupropion, chlorpromazine, clozapine, maprotiline, olanzapine, thioridazine, thiothixene, and tramadol.
• 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.
• Subjects taking ototoxic medications: Aminoglycosides, Cisplatin.
• Subjects in current episode of major depression
• History of bipolar disorder
• Subjects with history of seizure or first degree relative with seizure disorder
• 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
• Subjects with diagnosis of current alcohol related problems
• Subjects with history of stroke , aneurysm, or cranial neurosurgery
• Any condition that in the opinion of the study physician is likely to compromise their ability to safely participate in the study

Where it is running

• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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