A clinical research study investigating repetitive transcranial magnetic stimulation (rTMS) in treating persistent post-concussion symptoms in children compared to placebo/dummy treatment

Phase 2

• Conditions: Persistent post-concussion syndrome; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12619001118190
• Lead Sponsor: Associate Professor Karen Barlow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-12
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1.Male or female, 11-18 years of age inclusive (at time of initial pre-screening), currently experiencing post concussive symptoms.
2.Documentation of persistent post concussive symptoms as evidenced by two or more clinical symptoms: headache, difficulty concentrating or remembering, sleep problems, dizziness, fatigue or nausea/vomiting – not explained by another disorder.
3.Post concussive symptoms for more than/equal to 2 months.
4.No history of rTMS treatments.

Exclusion Criteria

1.Epilepsy or other seizure disorders.
2.Chronic treatment with psychotropic medication or any other medications deemed unsuitable for TMS application as deemed by the Investigator.
3.Neurological disorders, including moderate to severe learning difficulties.
4.Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
5.Females of child-bearing potential only: Pregnant as confirmed by urine pregnancy test at baseline visit; and unwillingness to use contraception from pre-screening to follow-up visit (if sexually active); currently breastfeeding.
6.No recreational drug use.

Study & Design

• Study Type: Interventional
• Study Design: Not specified