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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: navigated repetitive Transcranial 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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Medical University Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 30-459-ex 17/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No