Transcranial Magnetic Stimulation for Treatment of Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Device: Transcranial magnetic stimulation

• Registration Number: NCT02196025
• Lead Sponsor: University of Florida

Brief Summary

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that has been approved as a treatment of depression in patients that have not responded to a trial of one antidepressant medication. The investigators hypothesize that low frequency TMS exerts inhibitory effect on hyper excitable cortical state in patients with chronic insomnia and therefore is therapeutic. The investigators want to compare the change in insomnia scores between baseline and end of treatment in an open label trial with bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week days).

Detailed Description

Insomnia is a common clinical problem that affects about 25 million people in the US. Insomnia exacts health and economic consequences well beyond inadequate and non-restorative sleep. It increases healthcare costs, causes or adds to medical and psychiatric comorbidities, cognitive impairments, accidents, absenteeism and reduced quality of life. Treatment of insomnia is difficult and usually needs a multimodal approach incorporating various cognitive and behavioral approaches in addition to medication treatment. TMS and other neurophysiological studies have shown presence of a diffuse cortical hyper-arousal in patients with chronic insomnia. High frequency TMS (\>1 Hz) has been shown to be activating whereas low frequency TMS (\<1Hz) has been shown to be inhibitory in clinical and neurophysiological studies. TMS has been approved as a treatment of depression in patients who have not responded to a trial of at least one antidepressant medication. The goal of this study is to translate the knowledge learned from neurophysiological studies of insomnia to the clinical treatment of insomnia using TMS as the primary modality.

Aim: Compare the change in insomnia scores between baseline and end of treatment with bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week days).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-21
• Study Start: 2015-05
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Results First Submitted: 2023-09-20
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Results First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Patients referred for evaluation and management of insomnia to our sleep disorders clinic will be offered enrollment in this study
2. Patients must meet Diagnostic and Statistical Manual (DSM) IV criteria for Primary insomnia
3. Aged 21-65 years to target relatively healthy adults

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Exclusion Criteria

1. Patients with co-morbid depression
2. Substance abuse in last two weeks
3. No Psychotropic medication changes 2 weeks before start of TMS treatment and no changes during the 3 week treatment period
4. Patients with a major medical or psychiatric disorder that may be causing or contributing to insomnia: bipolar disorder, psychosis, anxiety disorders, dementia, seizure disorder and chronic pain
5. Patients with ferromagnetic material in their head or within 30 cm of the coil will be excluded

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcranial magnetic stimulation	Transcranial magnetic stimulation	Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index ( PSQI)	three weeks	Change in Pittsburgh sleep quality index scores at the end of three weeks of stimulation with transcranial magnetic stimulation. Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity Index ( ISI)	three weeks	Change in insomnia severity index scores at the end of three weeks stimulation with transcranial magnetic stimulation. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

Trial Locations

Locations (1)

UF @ Shands; 🇺🇸 Gainesville, Florida, United States