Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia (NCT02190084) | Clinical Trial Compass
CompletedPhase 4
Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia
United States20 participantsStarted 2014-05
Plain-language summary
Alzheimer's Dementia (AD) is a major public health problem. Apathy, a profound loss of motivation, is seen in majority of patients with AD. Dysfunction of the front of the brain and loss of dopamine, a type of neurochemical, in this part of brain results in apathy. Presence of apathy is linked to deficits in planning sequential tasks such as keeping a routine. Patients with apathy have poor physical function and their caregivers experience extra burden. Unfortunately there are no good medications to treat apathy. FDA has approved the use of brain stimulation by a magnet known as repetitive transcranial magnetic stimulation (rTMS), for treatment of depression. rTMS increases dopamine when applied to frontal lobe of brain so we propose that rTMS would be a good treatment option for apathy in AD. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and executive function better than sham treatment in those with AD.
Who can participate
Age range55 Years – 91 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects age ≥ 55 years,
✓. Diagnosis of Alzheimer's dementia meeting the DSM-IV TR criteria,
✓. Apathy Evaluation Scale-Clinician (AES-C) score of ≥ 30,
✓. Mini Mental Status Examination (MMSE) ≥ 18,
✓. Subjects who clear the TMS adult safety scale (TASS)
✓. On stable dose of antidepressants or dementia medicines (if applicable) for at least two months
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Apathy Evaluation Scale (AES)
Timeframe: 4 weeks
Trial details
NCT IDNCT02190084
SponsorCentral Arkansas Veterans Healthcare System
✕. 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