Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cortex for the Treatment of Chronic Pain

Study Overview
=================
Brief Summary
-----------------
This study investigated the effects of navigated repetitive Transcranial Magnetic Stimulation on nociception and quality of life in patients suffering from chronic pain conditions. Two cortical targets (dorsolateral prefrontal cortex/DLPFC and M1 area) were stimulated and compared to Sham stimulation.

Detailed Description
-----------------
From 34 patients, 24 completed the study. The M1-area was stimulated with 10 Hz rTMS while the DLPFC received a 5Hz stimulation. In total, 13 session were administered over a period of 36 weeks with most frequent stimulation in the first 4 weeks of the trial. Results were compared to Sham-TMS over the M1 area at the same schedule than the actual therapy. Outcome parameters included the German Pain Questionnaire (GPQ), the Depression, Anxiety and Stress Scale (DASS) and quality of life (QoL) with the SF-12 questionnaire.

Official Title
-----------------
Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cor-tex for the Treatment of Chronic Pain: a Randomized Place-bo-controlled Trial

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: navigated repetitive Transcranial Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 80 years clinical diagnosis of chronic LBP (low back pain) and or neck pain average resting pain-level > than 3 in the Numeric Rating Scale (0-10) no changes in pain medication 4 weeks at baseline no surgical procedures in the last 2 years Exclusion Criteria: metallic and electronic implants in the head, neck and chest medication e.g. tetracyclic antidepressants, antiviral, antipsychotic, opioid doses > 100mg orally/d history of frequent headache or tinnitus alcohol or drug abuse pregnant patients breastfeeding patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was conducted in a single-blinded, randomized, placebo-controlled design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: M1 stimulation<br>10 Hz stimulation of left motor area | Device: navigated repetitive Transcranial Stimulation<br>* High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.<br>|
| Active Comparator: DLPFC stimulation<br>5 Hz stimulation of left dorsolateral prefrontal cortex | Device: navigated repetitive Transcranial Stimulation<br>* High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.<br>|
| Sham Comparator: Sham TMS<br>Sham TMS over the left M1 area | Device: navigated repetitive Transcranial Stimulation<br>* High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale | 0-10 0 = no pain, 10 = worst pain | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Depression, Anxiety and Stress Scale (DASS) questionnaire. | 0- 21 for each item, higher scores indicate worse symptoms. Lower scores indicate a better outcome | 36 weeks |