Deep Brain Stimulation in Pediatric Populations: A Scoping Review of the Clinical Trial Landscape
Bibliographic record
Abstract
INTRODUCTION: There has been rapid advancement in the development of deep brain stimulation (DBS) as a treatment option for adults for neurological and neuropsychiatric conditions. Here, we present a scoping review of completed and ongoing clinical trials focused on DBS in pediatric populations, highlighting key knowledge gaps. METHODS: Three databases (PubMed, OVID, and Embase) and the clinicaltrials.gov registry were queried to identify clinical trials for DBS in pediatric cohorts (age ≤18 years). Prospective and retrospective case series were excluded. No restrictions were placed on the diagnoses or measured clinical outcomes. Individual patient demographics, diagnosis, DBS target, and primary endpoints were extracted and summarized. RESULTS: A total of 13 clinical trials were included in the final review, consisting of 9 completed trials (357 screened) and 4 ongoing trials (82 screened). Of the completed trials, 6 studied dystonia (both inherited and acquired; participants aged 4-18 years) and 3 studied drug-resistant epilepsy (participants aged 4-17 years). Among the 6 trials for dystonia, 5 used the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) as the primary endpoint. There were a total of 18 adverse events documented across 63 participants, with 5 of 9 studies reporting adverse events. Ongoing clinical trials are evaluating DBS for dystonia (N = 2), epilepsy (N = 1), and self-injurious behavior (N = 1). CONCLUSIONS: This scoping review summarizes the landscape of clinical trials for DBS in children and youth. In dystonia, further research is warranted with more relevant pediatric outcome measures and for understudied patient subgroups and targets. There are also significant gaps in our understanding of evaluating the role of DBS in other neurological and neurodevelopmental disorders in pediatric populations. INTRODUCTION: There has been rapid advancement in the development of deep brain stimulation (DBS) as a treatment option for adults for neurological and neuropsychiatric conditions. Here, we present a scoping review of completed and ongoing clinical trials focused on DBS in pediatric populations, highlighting key knowledge gaps. METHODS: Three databases (PubMed, OVID, and Embase) and the clinicaltrials.gov registry were queried to identify clinical trials for DBS in pediatric cohorts (age ≤18 years). Prospective and retrospective case series were excluded. No restrictions were placed on the diagnoses or measured clinical outcomes. Individual patient demographics, diagnosis, DBS target, and primary endpoints were extracted and summarized. RESULTS: A total of 13 clinical trials were included in the final review, consisting of 9 completed trials (357 screened) and 4 ongoing trials (82 screened). Of the completed trials, 6 studied dystonia (both inherited and acquired; participants aged 4-18 years) and 3 studied drug-resistant epilepsy (participants aged 4-17 years). Among the 6 trials for dystonia, 5 used the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) as the primary endpoint. There were a total of 18 adverse events documented across 63 participants, with 5 of 9 studies reporting adverse events. Ongoing clinical trials are evaluating DBS for dystonia (N = 2), epilepsy (N = 1), and self-injurious behavior (N = 1). CONCLUSIONS: This scoping review summarizes the landscape of clinical trials for DBS in children and youth. In dystonia, further research is warranted with more relevant pediatric outcome measures and for understudied patient subgroups and targets. There are also significant gaps in our understanding of evaluating the role of DBS in other neurological and neurodevelopmental disorders in pediatric populations.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.051 | 0.147 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.006 |
| Bibliometrics | 0.014 | 0.017 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".