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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04934150
• Other study ID #: 30-459-ex 17/18
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: June 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 30, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• navigated repetitive Transcranial Stimulation
High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale	0-10 0 = no pain, 10 = worst pain	36 weeks
Secondary	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