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

Medical University of Graz

Status: Completed

Conditions: Chronic Pain

Treatments: Device: navigated repetitive Transcranial Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04934150

30-459-ex 17/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 3 patient groups

M1 stimulation

Active Comparator group

Description:

10 Hz stimulation of left motor area

Treatment:

Device: navigated repetitive Transcranial Stimulation

DLPFC stimulation

Active Comparator group

Description:

5 Hz stimulation of left dorsolateral prefrontal cortex

Treatment:

Device: navigated repetitive Transcranial Stimulation

Sham TMS

Sham Comparator group

Description:

Sham TMS over the left M1 area

Treatment:

Device: navigated repetitive Transcranial Stimulation