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Trial · NCT07413562

Feasibility, Safety, and Preliminary Efficacy of Median Nerve Stimulation for Cognitive Dysfunction in Patients With Acute Traumatic Brain Injury

NCT07413562, Not applicable, Recruiting, Beijing Tiantan Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Feasibility, Safety, and Preliminary Efficacy of Median Nerve Stimulation for Cognitive Dysfunction in Patients With Acute Traumatic Brain Injury. Trials, record NCT07413562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07413562

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Feasibility, Safety, and Preliminary Efficacy of Median Nerve Stimulation for Cognitive Dysfunction in Patients With Acute Traumatic Brain Injury
NCT number
NCT07413562
Status
Recruiting
Phases
Not applicable
Enrollment
30 participants, estimated
Lead sponsor
Beijing Tiantan Hospital
Conditions
Traumatic Brain Injury, Cognitive Dysfunction
Interventions
Median nerve stimulation, Sham
First posted
2026-02-17
Last updated
2026-02-17

Source ClinicalTrials.gov

Registered outcomes27

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in global cognitive function assessed by the Mini-Mental State Examination(MMSE)Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
The MMSE will be used to evaluate global cognitive function. Assessments will be conducted by two trained occupational researchers who are blinded to group allocation and not involved in the intervention.
SecondaryGlobal cognitive function (MoCA)Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point screening tool evaluating multiple cognitive domains including attention, memory, language, executive function, and visuospatial ability. Higher scores indicate better cognitive performance, and a score below 26 suggests cognitive impairment.
SecondaryVerbal fluencyBaseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
Verbal fluency will be assessed using the Verbal Fluency Test, in which participants are asked to generate as many words as possible within 1 minute. The test evaluates language production and executive control, with higher word counts indicating better performance.
SecondaryLanguage functionBaseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
Language ability will be assessed using the Boston Naming Test, which requires participants to name a series of visually presented objects. Higher scores reflect better confrontation naming ability and language function.
SecondaryVisuospatial functionBaseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
Visuospatial ability will be assessed using the Rey-Osterrieth Complex Figure Test (RCFT), which evaluates visuospatial construction and visual memory through figure copying and recall tasks. Higher scores indicate better visuospatial performance.
SecondaryVerbal learning and memoryBaseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
Verbal learning and memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), a verbal learning task involving a 15-item word list learned over five trials. The delayed recall score represents the number of correctly recalled words (range: 0-15) after a 30-minute delay, with higher scores indicating better memory performance.
SecondaryExecutive functionBaseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
Executive function will be assessed using the Stroop Test and Trail Making Test A/B. The Stroop Test evaluates inhibitory control and cognitive flexibility, while the Trail Making Test assesses processing speed (Part A) and set-shifting ability (Part B). Better executive function is reflected by higher accuracy and shorter completion time.
SecondaryAttention and working memoryBaseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
Attention and working memory will be assessed using the Digit Symbol Test and Digit Span Test. The Digit Symbol Test evaluates attention and processing speed, whereas the Digit Span Test assesses working memory capacity through forward and backward recall tasks. Higher scores indicate better cognitive performance.
SecondaryNeuropsychiatric symptomsBaseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
Neuropsychiatric symptoms will be assessed using the Neuropsychiatric Inventory (NPI), which evaluates 12 neuropsychiatric symptom domains based on caregiver interviews, including both the caregiver's observations of patient behaviors and the associated caregiver distress. The total patient symptom score ranges from 0 to 144, and the caregiver distress score ranges from 0 to 60, with higher scores indicating greater symptom frequency, severity, and caregiver burden; a score of 0 represents the absence of symptoms or distress.
SecondarySleep qualityBaseline (Day 7 after injury), 1 month after injury, and 3 months after injury.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which consists of 19 self-rated items measuring seven domains of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleep medication, and (7) daytime dysfunction. The 19 items are aggregated into seven component scores, each ranging from 0 to 3, where 0 indicates no difficulty and 3 indicates severe difficulty. The component scores are summed to generate a global PSQI score ranging from 0 to 21, with higher scores indicating poorer overall sleep quality.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
42600067DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests9

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Complex Figure Copy and RecallSecondary outcomeConductCognition
Digit Span TestSecondary outcomeConductCognition
Picture Naming TestSecondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition
Symbol CodingSecondary outcomeConductCognition
Trail Making Test ASecondary outcomeConductCognition
Trail Making Test BSecondary outcomeConductCognition
Verbal FluencySecondary outcomeConductCognition
Verbal LearningSecondary outcomeConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07413562

GET https://conductscience.org/api/trials/v1/NCT07413562/registered?page=2