- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190084
Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: 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.
Specific Aims: To determine the efficacy of rTMS to the dorsolateral prefrontal cortex (DLPFC) in treating apathy in mild AD in comparison to sham treatment.
• To compare the efficacy of rTMS to the DLPFC on executive function in mild AD in comparison to sham treatment.
Research Plan: Current study is a prospective randomized sham controlled study of daily rTMS.
Methods: Up to 500 subjects will be pre-screened to enroll 100 subjects for screening and randomizing up to 50 subjects to analyze 20 completers. Subjects with mild AD and apathy will be randomly assigned to rTMS or sham treatment after consent. All subjects will be tested for memory, behavioral problems, functioning and caregiver burden. Apathy will be assessed using the Apathy Evaluation Scale. Memory, executive function, functional status and caregiver burden will be assessed. Subjects will receive daily treatments for 4 weeks with either rTMS or sham coil for a total of 20 treatments. Neither the subject nor the investigators will know which treatment the subject is receiving. Testing will be repeated at the end of 4 weeks and at 8 and 12 weeks after treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Central Arkansas Veterans Healthcare System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
20 treatment sessions are given over a four week period.
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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.
20 treatment sessions are given over a four week period.
Other Names:
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Sham Comparator: Sham coil treatment
Neurostar repetitive transcranial magnetic stimulator.
20 treatments identical in duration will be administered over a four week period.
|
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.
20 treatment sessions are given over a four week period.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apathy Evaluation Scale (AES)
Time Frame: 4 weeks
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AES is an 18-item scale that assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trials making test
Time Frame: 4 weeks
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Widely used test for assessment of executive function.
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4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exit 25
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 547461
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Apathy
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University Hospital, Strasbourg, FranceRecruiting
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Centre Hospitalier Universitaire de NiceCompleted
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University Hospital, BordeauxRecruiting
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Institut National de la Santé Et de la Recherche...Unknown
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US Department of Veterans AffairsCompleted
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Indiana University School of MedicineCompletedDepression | Sexual Dysfunction | Apathy | Side EffectsUnited States
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University Hospital, MontpellierRecruiting
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Institut National de la Santé Et de la Recherche...Unknown
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RIVAGESRecruitingNeurocognitive Disorders | Virtual Reality | Aged | Apathy in DementiaFrance
Clinical Trials on Neurostar repetitive transcranial magnetic stimulator
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Central Arkansas Veterans Healthcare SystemUnknownMild Cognitive Impairment | ApathyUnited States
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NeuroneticsWithdrawnMajor Depressive DisorderUnited Kingdom
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Paul E. CroarkinTerminated
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Paul E. CroarkinTerminated
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US Department of Veterans AffairsUniversity of FloridaCompleted
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James A. Haley Veterans Administration HospitalCompletedDepression | Posttraumatic Stress DisorderUnited States
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University of MichiganNational Institute of Mental Health (NIMH); NeuroneticsCompleted
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Northwestern UniversityNeuroneticsCompletedDepression | Anxiety | Cancer in Remission (Any Type or Stage)United States
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University of BrasiliaCompletedObsessive Compulsive DisorderBrazil
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Eisenhower Army Medical CenterAugusta University; The Geneva Foundation; Congressionally Directed Medical Research...CompletedSuicidal Ideation | Suicide | Suicidal Intention | Suicidal Impulses | Suicidal and Self-Injurious Behavior | Suicidal DepressionUnited States