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Behavioural Intervention
Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment:Pilot Study
Phase 4
Waitlist Available
Led By Prasad R Padala, MD, MS
Research Sponsored by Central Arkansas Veterans Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
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
Eligible Conditions
- Apathy
- Mild Cognitive Impairment
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Apathy Evaluation Scale (AES)
Secondary study objectives
Trials making test
Other study objectives
Exit 25
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: transcranial magnetic stimulatorActive Control1 Intervention
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.
Group II: Sham coil treatmentPlacebo Group1 Intervention
Neurostar repetitive transcranial magnetic stimulator. 10 treatments identical in duration will be administered over a two week period.
Find a Location
Who is running the clinical trial?
Central Arkansas Veterans Healthcare SystemLead Sponsor
23 Previous Clinical Trials
342,888 Total Patients Enrolled
2 Trials studying Apathy
145 Patients Enrolled for Apathy
Prasad R Padala, MD, MSPrincipal InvestigatorCentral Arkansas Veterans Healthcare System
1 Previous Clinical Trials
15 Total Patients Enrolled