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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04457466
Other study ID # 10042017
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date July 1, 2020

Study information

Verified date February 2022
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Persistent pain may lead to several alterations in the brain activity and sensory perception (i.e. pain). Around 80% of professional musicians experience prolonged episodes of musculoskeletal pain throughout their careers, a percentage that is four times higher than in the general population. With this background, the intended experiment aims at understanding the role of several biological factors associated to sensorimotor training that can lead to alteration of the brain activity and, consequently, pain processing.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date July 1, 2020
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: Healthy men and women Speak and understand English. General exclusion criteria are: - Pregnancy - Drug addiction defined as the use of cannabis, opioids or other drugs - Previous neurologic or mental illnesses - Presence of a history of trauma or neurologic entrapment syndromes to the arm regions. - Lack of ability to cooperate - Frequent computer gamer ( > 9 hours/week)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nerve Growth Factor
Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.

Locations

Country Name City State
Denmark Aalborg University Aalborg Nordjylland

Sponsors (4)

Lead Sponsor Collaborator
Aalborg University Danish National Research Foundation, Lundbeck Foundation, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain rating Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable) Changes from baseline measured at day 3 and day 8
Primary Cortical Sensory Evoked Potentials Electrical stimulation will be elicited to record sensory evoked potentials using electroencephalography (EEG) Changes from baseline measured at day 3 and day 8
Primary Motor Evoked Potentials Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs) Changes from baseline measured at day 3 and day 8
Primary Brain connectivity Continuous electroencephalography recording will be used to explore connectivity between brain areas Changes from baseline measured at day 3 and day 8
Secondary Questionnaires Questionnaires about pain and muscle soreness (Pain catastrophization; State and Trait anxiety; Pain vigilance) Changes from baseline measured at day 3 and day 8
Secondary Pressure pain thresholds Pressure applied to the surface of the skin using a handheld algometer Changes from baseline measured at day 3 and day 8
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