NCT04934150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

June 14, 2021

Last Update Submit

June 28, 2021

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale

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

    36 weeks

Secondary Outcomes (1)

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

    36 weeks

Study Arms (3)

M1 stimulation

ACTIVE COMPARATOR

10 Hz stimulation of left motor area

Device: navigated repetitive Transcranial Stimulation

DLPFC stimulation

ACTIVE COMPARATOR

5 Hz stimulation of left dorsolateral prefrontal cortex

Device: navigated repetitive Transcranial Stimulation

Sham TMS

SHAM COMPARATOR

Sham TMS over the left M1 area

Device: navigated repetitive Transcranial Stimulation

Interventions

navigated repetitive Transcranial StimulationDEVICE

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

DLPFC stimulationM1 stimulationSham TMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sham stimulation was provided by turning the TMS coil to the non-stimulating side.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study was conducted in a single-blinded, randomized, placebo-controlled design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 22, 2021

Study Start

February 1, 2019

Primary Completion

March 31, 2020

Study Completion

October 30, 2020

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)