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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: navigated repetitive Transcranial Stimulation

• Registration Number: NCT04934150
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-10-30
• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M1 stimulation	navigated repetitive Transcranial Stimulation	10 Hz stimulation of left motor area
DLPFC stimulation	navigated repetitive Transcranial Stimulation	5 Hz stimulation of left dorsolateral prefrontal cortex
Sham TMS	navigated repetitive Transcranial Stimulation	Sham TMS over the left M1 area

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale	36 weeks	0-10 0 = no pain, 10 = worst pain

Secondary Outcome Measures

Name	Time	Method
Self-reported "Depression, Anxiety and Stress Scale" (DASS) questionnaire.	36 weeks	0- 21 for each item, higher scores indicate worse symptoms. Lower scores indicate a better outcome

Trial Locations

Locations (1)

Medical University Graz; 🇦🇹 Graz, Styria, Austria