None listed
Conditions
Brief summary
Repetitive Transcranial Magnetic Stimulation (rTMS) uses changing magnetic fields that alter activity in a part of the brain. This randomized control trial will assess 2 weeks of rTMS treatment in children with persistent post-concussions syndrome (PPCS) compared to sham treatment, and if a subsequent 2 week rTMS treatment leads to further PPCS improvement.
Interventions
Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neuromodulation that uses a series of brief magnetic pulses to increase or decrease cortical excitability in specific brain regions. These trains of pulses are non-invasive, painless magnetic stimulations which modulates neuronal activity to induce neuroplasticity in the brain. In general, where rTMS is used as a treatment, it is intended to “normalise” overactivity or underactivity within a brain region.
All TMS int
Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neuromodulation that uses a series of brief magnetic pulses to increase or decrease cortical excitability in specific brain regions. These trains of pulses are non-invasive, painless magnetic stimulations which modulates neuronal activity to induce neuroplasticity in the brain. In general, where rTMS is used as a treatment, it is intended to “normalise” overactivity or underactivity within a brain region. All TMS interventions in this study will take place at the Child Health Research Centre (CHRC) KidStim neuromodulation Laboratory in Brisbane, Australia. TMS will be delivered by research investigators and personnel trained and experienced in giving TMS. Children aged 11-18 years experiencing post concussion symptoms for 2 or more months will be asked to participate. Participants will be invited to have a structural and functional MRI at Herston Imaging Research Facility and high-density EEG at CHRC pre- and post-treatment. This will allow review of any changes before and after treatment. It will also enable real-time and accurate positioning of an rTMS coil over the treatment stimulation site through the upload of the individual's MRI in the TMS neuronavigation system. At the beginning of each TMS session, a “motor threshold” procedure is performed. The lowest intensity of the machine that can reliably produce this twitch is the motor threshold, and this is used to set the TMS intensity. Briefly, surface EMG electrodes are placed of the right first dorsal interosseous muscle (FDI) to record motor evoked potentials (MEP). Single pulse TMS is then applied over the left primary motor cortex to determine the ideal location (hotspot) for maximal evoked potentials. The RMT is then defined as the stimulator intensity required to elicit MEP > 0.5mV in 5 of 10 consecutive trials. Interventional rTMS will consist of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds over the dorsolateral prefrontal cortex (DLPFC). Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for two weeks (10 treatment days total), where up to 54 participants will be randomised to receive either active rTMS or sham rTMS (placebo with no magnetic field). A further optional 10 treatment sessions over 2 weeks will be offered, where all participants will receive active rTMS only. During participation, participants will be asked to complete a number of questionnaires and assessments measuring symptoms, quality of life, mood, strength and difficulties and neurocognitive abilities.
Sponsors
Associate Professor Karen Barlow
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
11 Years to 18 Years
Healthy volunteers
No
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.
Outcome results
None listed