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Completed

NCT Number: NCT04934150

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz

Graz, Styria, 8010, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

navigated repetitive Transcranial Stimulation

Device

High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.

Primary outcomes

  1. Numeric Rating Scale

    Time frame: 36 weeks

    0-10 0 = no pain, 10 = worst pain

Secondary outcomes

  1. Self-reported "Depression, Anxiety and Stress Scale" (DASS) questionnaire.

    Time frame: 36 weeks

    0- 21 for each item, higher scores indicate worse symptoms. Lower scores indicate a better outcome

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2021
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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