Transcranial Magnetic Stimulation for Treatment of Insomnia
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 3/9/2019 |
| Start Date: | May 2015 |
| End Date: | September 2019 |
| Contact: | Khurshid Khurshid, MD |
| Email: | khurshid@ufl.edu |
| Phone: | 352-594-1865 |
An Open Label Trial of Sequential Bifrontal Low Frequency Repetitive Transcranial Magnetic Stimulation (r-TMS) in the Treatment of Primary 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).
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).
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).
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).
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 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
We found this trial at
1
site
Gainesville, Florida 32610
Principal Investigator: Richard Holbert, MD
Phone: 352-514-1865
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