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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-10-30

Brief Summary

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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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Detailed Description

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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

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Study Groups

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M1 stimulation

10 Hz stimulation of left motor area

Group Type ACTIVE_COMPARATOR

navigated repetitive Transcranial Stimulation

Intervention Type DEVICE

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

DLPFC stimulation

5 Hz stimulation of left dorsolateral prefrontal cortex

Group Type ACTIVE_COMPARATOR

navigated repetitive Transcranial Stimulation

Intervention Type DEVICE

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

Sham TMS

Sham TMS over the left M1 area

Group Type SHAM_COMPARATOR

navigated repetitive Transcranial Stimulation

Intervention Type DEVICE

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

Interventions

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navigated repetitive Transcranial Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No