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One (1) TMS treatment per day plus CBT-I for Mild Cognitive Impairment
N/A
Waitlist Available
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Aged 65 years or older
* Speak and read English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 3, week 13, 6 months
Summary
The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.
Eligible Conditions
- Mild Cognitive Impairment
- Insomnia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 3, week 13, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3, week 13, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insomnia Severity Index
Paired Associative Learning test (CANTAB)
Spatial Working Memory test (CANTAB)
Secondary study objectives
Center for Epidemiologic Studies Depression scale
Match to Sample Visual Search test (CANTAB)
Multidimensional Fatigue Symptoms Inventory
+7 moreOther study objectives
Cortical Plasticity
Trial Design
2Treatment groups
Active Control
Group I: One (1) TMS treatment per day plus CBT-IActive Control2 Interventions
One (1) daily treatment of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program
Group II: Two (2) TMS treatments per day plus CBT-IActive Control2 Interventions
Two (2) daily treatments, spaced 1 hour apart, of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program
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Who is running the clinical trial?
University of VirginiaOTHER
782 Previous Clinical Trials
1,315,695 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
854 Previous Clinical Trials
12,930,921 Total Patients Enrolled
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