A New Combined Treatment for Post Concussion Syndrome: Pilot Trial
Research type
Research Study
Full title
A New Combined Treatment for Post Concussion Syndrome: Pilot Trial
IRAS ID
1005607
Contact name
Paul L Chazot
Contact email
Sponsor organisation
Durham University
ISRCTN Number
ISRCTN45733939
Research summary
Post-Concussion Syndrome (PCS) is a serious and complex disorder for which there is currently no cure. PCS is profoundly debilitating, significantly impacts quality of life and can force early career retirement. The syndrome can develop following a mild or traumatic brain injury but can also occur in association with post-traumatic stress disorder. PCS severely affects an individual’s quality of life through somatic symptoms such as persistent headache, migraine, dizziness, fatigue, sleep disturbances, and blurred vision, cognitive complaints such as forgetfulness and concentration difficulties, and an overlay of serious physical and emotional issues. The complex pathology and presentation of PCS presents an ongoing challenge in clinical practice and a significant burden to patients, families and health care systems. In some, PCS can persist for years, with increased or differential reporting of symptoms at follow-up compared to initial presentation. Current approaches for treating PCS focus on the relief of individual symptoms rather than addressing the underlying pathology. This has limitations in that a complete resolution of the syndrome is difficult if not impossible to achieve. The development of effective treatment solutions for PCS necessitates consideration of the basic science and underlying pathophysiology, which can be largely explained through cerebrovascular disruption, blood brain barrier defects, and changes in neuronal physiology and homeostasis. Our proposed approach for the treatment of PCS, involves the repurposing and combination of two licensed drugs which address the underlying pathology of PCS. This initial study is a single-arm, pilot trial, over 3 months. The data generated by this trial, if favourable, will be used to inform a grant application for a full multi-centre double-blind efficacy trial.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0285
Date of REC Opinion
23 Dec 2022
REC opinion
Further Information Favourable Opinion