CBT-I + TMS for Insomnia in Mild Cognitive Impairment

Recruiting in Palo Alto (17 mi)

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with mild cognitive impairment who also struggle with insomnia. Participants should be interested in non-medication treatments to improve sleep quality.

Inclusion Criteria

I have had trouble falling or staying asleep, causing me significant distress for the past three months.

I am 65 years old or older.

I have been diagnosed with mild cognitive impairment.

Exclusion Criteria

Current diagnosis of major psychiatric disorder (well-controlled depression or anxiety is permitted)

Alcohol or drug abuse within the past year

I have been diagnosed with a neurological condition affecting my sleep.

Participant Groups

The study tests a combination of transcranial magnetic stimulation (TMS), a gentle brain stimulation technique, and cognitive behavioral therapy for insomnia (CBT-I), which is a psychological treatment.

Group I: One (1) TMS treatment per day plus CBT-I Active Control 2 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-I Active Control 2 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

Cognitive behavioral therapy for insomnia (CBT-I) is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia disorder
• Major depressive disorder with comorbid insomnia
• Traumatic brain injury-related insomnia
• Post-traumatic stress symptoms

🇪🇺 Approved in European Union as Cognitive Behavioural Therapy for Insomnia for:

• Insomnia disorder
• Major depressive disorder with comorbid insomnia

🇨🇦 Approved in Canada as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia disorder
• Major depressive disorder with comorbid insomnia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Beth Israel Deaconess Medical Center Boston, MA

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center Lead Sponsor

University of Virginia Collaborator

References