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Behavioral Intervention

CBT-I + TMS for Insomnia in 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

Clinical diagnosis of MCI

Must not have

Diagnosis of Parkinson's disease, Huntington's disease, Lewy-Body disease, or other neurological condition known to impact sleep

Evidence of significant cognitive impairment or dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 3, week 13, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new treatment that combines brain stimulation using transcranial magnetic stimulation with cognitive behavioral therapy for insomnia to improve sleep quality in people with mild cognitive impairment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include discomfort at the TMS application site, headache, lightheadedness, or temporary hearing changes due to the noise during TMS. CBT-I typically does not have physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I have been diagnosed with mild cognitive impairment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with significant cognitive impairment or dementia.

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I am currently receiving treatment for insomnia.

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I do not have untreated severe sleep disorders like sleep apnea.

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 3, week 13, 6 months for reporting.

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 more

Other study objectives

Cortical Plasticity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met