Transcranial Magnetic Stimulation for Treatment of Insomnia

NCT ID: NCT02196025

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2021-07-21

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).

Conditions

Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

repetitive Transcranial magnetic stimulation; r-TMS; TMS

Eligibility Criteria

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

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Holbert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF @ Shands

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB201400335

Identifier Type: -

Identifier Source: org_study_id