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

Primary Purpose

Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

navigated repetitive Transcranial Stimulation

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Medical University Graz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

M1 stimulation

DLPFC stimulation

Sham TMS

Arm Description

10 Hz stimulation of left motor area

5 Hz stimulation of left dorsolateral prefrontal cortex

Sham TMS over the left M1 area

Outcomes

Primary Outcome Measures

Numeric Rating Scale

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04934150

First Posted

June 14, 2021

Last Updated

June 28, 2021

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT04934150

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

March 31, 2020 (Actual)

Study Completion Date

October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The study was conducted in a single-blinded, randomized, placebo-controlled design

Masking

Participant

Masking Description

Sham stimulation was provided by turning the TMS coil to the non-stimulating side.

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

M1 stimulation

Arm Type

Active Comparator

Arm Description

10 Hz stimulation of left motor area

Arm Title

DLPFC stimulation

Arm Type

Active Comparator

Arm Description

5 Hz stimulation of left dorsolateral prefrontal cortex

Arm Title

Sham TMS

Arm Type

Sham Comparator

Arm Description

Sham TMS over the left M1 area

Intervention Type

Device

Intervention Name(s)

navigated repetitive Transcranial Stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Numeric Rating Scale

Description

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

Time Frame

36 weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Medical University Graz

City

Graz

State/Province

Styria

ZIP/Postal Code

8010

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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