N/A
Completed N=23
Transcranial Magnetic Stimulation for Treatment of Insomnia
Source: ClinicalTrials.gov NCT02196025 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Pittsburgh Sleep Quality Index ( PSQI) — 12.50; 11.70; 10.37; 9.50 score on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pittsburgh Sleep Quality Index ( PSQI) |
12.50; 11.70; 10.37; 9.50 | — |
| SECONDARY Insomnia Severity Index ( ISI) |
20.05; 18.37; 13.94; 10.29 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02196025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.