Chronic PainNCT04934150
Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cortex for the Treatment of Chronic Pain
A study testing navigated repetitive Transcranial Stimulation in people with Chronic Pain, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- navigated repetitive Transcranial Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- navigated repetitive Transcranial Stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigated repetitive Transcranial StimulationDevice
High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.
| Study group | Role | What they receive |
|---|---|---|
| M1 stimulation | Active comparator | 10 Hz stimulation of left motor area Receives: Device: navigated repetitive Transcranial Stimulation |
| DLPFC stimulation | Active comparator | 5 Hz stimulation of left dorsolateral prefrontal cortex Receives: Device: navigated repetitive Transcranial Stimulation |
| Sham TMS | Sham comparator | Sham TMS over the left M1 area Receives: Device: navigated repetitive Transcranial Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
0-10 0 = no pain, 10 = worst pain
Measured: 36 weeks
Secondary outcomes (1)
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
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Feb 2019
- Primary completion31 Mar 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted in a single-blinded, randomized, placebo-controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934150
- Sponsor's protocol ID
- 30-459-ex 17/18
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04934150
- Acronym / sponsor ID
- 30-459-ex 17/18
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study was conducted in a single-blinded, randomized, placebo-controlled design
| Arm | Type | Receives |
|---|---|---|
| M1 stimulation | Active comparator | Device: navigated repetitive Transcranial Stimulation10 Hz stimulation of left motor area |
| DLPFC stimulation | Active comparator | Device: navigated repetitive Transcranial Stimulation5 Hz stimulation of left dorsolateral prefrontal cortex |
| Sham TMS | Sham comparator | Device: navigated repetitive Transcranial StimulationSham TMS over the left M1 area |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| navigated repetitive Transcranial StimulationHigh frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas. | Device | DLPFC stimulation, M1 stimulation, Sham TMS |
Primary outcome
Numeric Rating Scale
Time frame: 36 weeks
0-10 0 = no pain, 10 = worst pain
1 secondary outcome
Self-reported "Depression, Anxiety and Stress Scale" (DASS) questionnaire.
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navigated repetitive Transcranial Stimulation in people with Chronic Pain, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.