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Behavioural Intervention
Transcranial Magnetic Stimulation for Mild Cognitive Impairment (TAMCI Trial)
N/A
Recruiting
Led By Prasad R. Padala, MBBS
Research Sponsored by VA Office of Research and Development
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 through study completion, an average of 1 year
Summary
This trial will study whether or not magnetic stimulation can help treat apathy in older Veterans with memory problems.
Who is the study for?
This trial is for older Veterans with mild memory problems who show signs of apathy. They must meet specific criteria for Mild Cognitive Impairment, have a caregiver, score at least 23 on the MMSE (a test of mental function), and if taking antidepressants, be on a stable dose for one month.
What is being tested?
The study tests whether Transcranial Magnetic Stimulation (TMS) can improve motivation, memory, and functioning in participants. It involves real or sham TMS over 20 sessions targeting the brain's frontal area. The study also examines genetic factors that may influence response to treatment.
What are the potential side effects?
While not explicitly stated here, common side effects of TMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms in facial muscles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Apathy Evaluation Scale Score
Secondary study objectives
Change in Conner's Continuous Performance Test Commission Error percentage
Change in Modified Mini Mental State Examination Score
Other study objectives
Functional Activities Questionnaire
Neuropsychiatric Inventory - Questionnaire
T-MoCA
+1 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Apathy +, rTMS -Active Control1 Intervention
This arm will be followed without intervention
Group II: rTMSActive Control1 Intervention
This group will be randomized to receive rTMS treatment
Group III: ShamPlacebo Group1 Intervention
This group will be randomized to receive sham treatment
Find a Location
Who is running the clinical trial?
University of ArkansasOTHER
494 Previous Clinical Trials
150,422 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,523 Total Patients Enrolled
Central Arkansas Veterans Healthcare SystemFED
23 Previous Clinical Trials
3,394 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on the same dose of antidepressants for at least a month.You don't have someone who can take care of you during the study.You have a score lower than 23 on the MMSE (Mini-Mental State Examination) test.You have mild cognitive impairment (MCI) that meets the standards set by the Mayo Clinic.The study measures apathy using a tool called the NPI.
Research Study Groups:
This trial has the following groups:- Group 1: Apathy +, rTMS -
- Group 2: rTMS
- Group 3: Sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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