Skip to main content
OpenTrials
Completed

NCT Number: NCT02196025

Transcranial Magnetic Stimulation for Treatment of Insomnia

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF @ Shands

Gainesville, Florida, 32610, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with co-morbid depression
  • Substance abuse in last two weeks
  • No Psychotropic medication changes 2 weeks before start of TMS treatment and no changes during the 3 week treatment period
  • 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
  • Patients with ferromagnetic material in their head or within 30 cm of the coil will be excluded

Treatment and study plan

Transcranial Magnetic Stimulation

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.

Other names: repetitive Transcranial magnetic stimulation, r-TMS, TMS

Primary outcomes

  1. Pittsburgh Sleep Quality Index ( PSQI)

    Time frame: 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 outcomes

  1. Insomnia Severity Index ( ISI)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

An Open Label Trial of Sequential Bifrontal Low Frequency Repetitive Transcranial Magnetic Stimulation (r-TMS) in the Treatment of Primary Insomnia

Acronym: TMSI

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2014
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.