Effect of Transcranial Direct Current Stimulation on Postoperative Delirium in Elderly Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHuazhong University of Science and Technology
About this trial
To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing the incidence of postoperative delirium (POD) in elderly patients undergoing hip fracture surgery.
This single-center, double-blind, randomized controlled trial will enroll participants aged 65 years and older, scheduled for elective hip surgery under spinal anesthesia. Participants will be randomly assigned to either the active-tDCS group or the sham-tDCS group. The active-tDCS group will receive two sessions: one pre-surgery and one post-surgery, with electrodes positioned over the left dorsolateral prefrontal cortex and the right supraorbital area. Each session includes 15-second ramp-up phase at the start, 20 minutes simulation with 2 mA current and 15-second ramp-down phase at the end. The sham-tDCS group will receive two sham procedures with no actual current delivered. Functional brain activity will be monitored before and after each session or sham procedure to assess changes in cortical activation and connectivity using functional near-infrared spectroscopy (fNIRS). The primary outcome measure will be the incidence of POD, assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). Secondary outcomes include the severity of delirium, postoperative pain, anxiety, depression, cognitive function, and sleep quality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
active tDCS
DeviceThe active-tDCS group will receive a 15-second ramp up phase at the start, 2 mA of tDCS for 20 minutes and a 15-second ramp down phase at the end.
sham tDCS
DeviceThe sham-tDCS group will only receive the 15-second ramp up phase at the beginning and the 15-second ramp down phase at the end of each session, without the continuous 2 mA current for 20 minutes
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: active tDCSActive comparator 1 intervention
Group B: sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of postoperative delirium
Delirium will be assessed during the first three postoperative days.The Confusion Assessment Method (CAM) assessment is based on the four key features of delirium: acute onset and fluctuating course, disorganized thinking, inattention, and altered levels of consciousness. Investigators will also consult the medical record or contact a family member, friend, or health care provider who knows the patient well to gather additional information regarding the patient's symptoms.
Time frame
postoperative days 1, 2 and 3Secondary outcomes
1
Subtypes of postoperative delirium.
Delirium subtypes will be assessed using the Richmond Agitation Sedation Scale (RASS) . Hyperactive delirium is characterized by symptoms ranging from mild restlessness to persistent motor activity and irritability. Conversely, hypoactive delirium is characterized by one or more of the following features: reduced or absent movement, minimal verbal communication despite stimulation, and a lack of responsiveness. Mixed delirium is characterized by rapid fluctuations between the hyperactive and hypoactive states.
Time frame
postoperative days 1, 2 and 32
pain score
Pain at rest and during movement will be assessed using the Numeric Rating Scale (NRS) , an 11-point scale where 0 denotes no pain and 10 represents the worst possible pain.
Time frame
postoperative days 1, 2 and 3Sponsors and contacts
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Source ClinicalTrials.gov