Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study.
Nicholas D SchiffJoseph T GiacinoChristopher R ButsonEun Young ChoiJonathan L BakerKyle P O'SullivanAndrew P JansonMichael BerginHelen M Bronte-StewartJason ChuaLaurel DeGeorgeSureyya DikmenAdam FogartyLinda M GerberMark KrelJose MaldonadoMatthew RadovanSudhin A ShahJason H SuNancy TemkinThomas TourdiasJonathan D VictorAbigail WatersStephanie A Kolakowsky-HaynerJoseph J FinsAndre G MachadoBrian K RuttJaimie M HendersonPublished in: Nature medicine (2023)
Converging evidence indicates that impairments in executive function and information-processing speed limit quality of life and social reentry after moderate-to-severe traumatic brain injury (msTBI). These deficits reflect dysfunction of frontostriatal networks for which the central lateral (CL) nucleus of the thalamus is a critical node. The primary objective of this feasibility study was to test the safety and efficacy of deep brain stimulation within the CL and the associated medial dorsal tegmental (CL/DTTm) tract.Six participants with msTBI, who were between 3 and 18 years post-injury, underwent surgery with electrode placement guided by imaging and subject-specific biophysical modeling to predict activation of the CL/DTTm tract. The primary efficacy measure was improvement in executive control indexed by processing speed on part B of the trail-making test.All six participants were safely implanted. Five participants completed the study and one was withdrawn for protocol non-compliance. Processing speed on part B of the trail-making test improved 15% to 52% from baseline, exceeding the 10% benchmark for improvement in all five cases.CL/DTTm deep brain stimulation can be safely applied and may improve executive control in patients with msTBI who are in the chronic phase of recovery.ClinicalTrials.gov identifier: NCT02881151 .
Keyphrases
- deep brain stimulation
- traumatic brain injury
- parkinson disease
- severe traumatic brain injury
- obsessive compulsive disorder
- minimally invasive
- randomized controlled trial
- working memory
- open label
- high resolution
- mental health
- lymph node
- neuropathic pain
- high intensity
- spinal cord injury
- atrial fibrillation
- surgical site infection