Mild Cognitive Impairment Clinical Trial
Official title:
Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment:Pilot Study
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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