NCT03263884

Brief Summary

The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

August 24, 2017

Last Update Submit

March 2, 2018

Conditions

Pain Relief

Keywords

nerve growth factorrepetitive transcranial magnetic stimulationdorsolateral prefrontal cortex

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)

    Change from baseline at 2 weeks

Secondary Outcomes (6)

  • Muscle soreness

    Change from baseline at 2 weeks

  • Patient-rated Tennis Elbow Evaluation

    Change from baseline at 2 weeks

  • Attention network test

    Change from baseline at 2 weeks

  • Pressure pain thresholds

    Change from baseline at 2 weeks

  • Cuff pressure algometry

    Change from baseline at 2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Real treatment group

EXPERIMENTAL

Transcranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or "coil", is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction. The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.

Device: Repetitive trancranial magnetic stimulation (rTMS) group

Sham treatment group

SHAM COMPARATOR

Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation

Device: Sham group

Interventions

Repetitive trancranial magnetic stimulation (rTMS) groupDEVICE

Repetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.

Real treatment group
Sham groupDEVICE

A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.

Sham treatment group

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • Speak and understand English.

You may not qualify if:

  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses
  • Lack of ability to cooperate
  • History of chronic pain or current acute pain
  • Previous experience with rTMS
  • Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
  • Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Enrico De Martino, MD

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

August 1, 2017

Primary Completion

November 30, 2017

Study Completion

February 28, 2018

Last Updated

March 5, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)