Tag: Clinical trial

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Effect of transcranial magnetic stimulation on prognosis in patients with postherpetic neuralgia and comorbid depression undergoing interventional neuromodulation therapy: protocol for a randomized double-blind placebo-controlled trial

BackgroundPostherpetic neuralgia (PHN) is often accompanied by depression, creating a vicious cycle that exacerbates symptoms and contributes to suboptimal treatment outcomes, even with interventional therapies. Repetitive transcranial magnetic stimulation (rTMS) has demonstrated potential in alleviating both pain and mood disturbances. However, its efficacy in enhancing prognosis when used alongside interventional neuromodulation therapy for PHN accompanied by depression remains inadequately explored and requires further investigation.ObjectiveThis study aims to generate preliminary evidence on the efficacy and safety of rTMS in enhancing prognosis and alleviating pain in patients with PHN and mild to moderate depression undergoing interventional neuromodulation therapy.MethodsThis study is a single-center, randomized, double-blind, placebo-controlled trial involving 174 adult patients with PHN. Participants will be randomly assigned, stratified by interventional neuromodulation therapy, to either the rTMS group (n=87) or the control group (n=87). Both groups will undergo either 10 Hz rTMS or sham stimulation for five consecutive days. The primary outcome is the incidence of poor prognosis at 3 months post-discharge. Secondary outcomes include the incidence of poor prognosis at 6 months post-discharge; Visual Analog Scale (VAS) sleep scores; short-form McGill Pain Questionnaire (SF-MPQ) scores; Self-Rating Depression Scale (SDS) scores; patient satisfaction; Pain Disability Index (PDI) scores; Multidimensional Fatigue Inventory-20 (MFI-20) scores; pregabalin oral doses; and the need for tramadol or antidepressants. Safety outcomes will include assessments of headache, pain at the stimulation site, neck pain, insomnia, muscle soreness, dizziness, nausea, tinnitus, irritability, tachycardia (heart rate > 100 bpm), and epilepsy. Data will be analyzed using a modified intention-to-treat approach.DiscussionThis study aims to provide preliminary evidence on the efficacy and safety of 10 Hz rTMS in improving prognosis and alleviating pain in PHN patients with mild to moderate depression undergoing interventional pain management.Trial registrationhttps://www.chictr.org.cn/bin/project/edit?pid=261070, identifier ChiCTR2500096978.
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Prefrontal and hippocampal microstructural gray matter following cognitive training under moderate hypoxia in mood disorders: a randomized controlled trial

BackgroundCognitive impairment persists during partial or full remission in 50–70% of individuals with mood disorders and impacts daily functioning and clinical prognosis. Preclinical evidence suggests that extended exposure to moderate hypoxia, combined with motor-cognitive learning, may elevate neuroplasticity and improve cognition. In these individuals with remitted mood disorders, we found that cognitive training under repeated moderate normobaric hypoxia improved executive function, and here investigate neurobiological mechanisms.MethodsParticipants with major depressive disorder (MDD) or bipolar disorder (BD) in partial or full remission were randomized to 3 weeks of 3.5-h daily normobaric hypoxia (12% O2) combined with cognitive training five to 6 days per week or treatment-as-usual (TAU). Participants were assessed with cognitive tests and diffusion-weighted MRI at baseline and 1 month after treatment completion (week 8) as part of the ALTIBRAIN trial (ClinicalTrials.gov: NCT06121206). Prefrontal and hippocampal gray matter microstructure were modelled with Neurite Orientation Dispersion and Density Imaging (NODDI).ResultsFifty-seven participants (mean age 39 years, SD: 13, 70% female) with baseline MRI data were included. No significant effects of hypoxia-cognition training vs. TAU on neurite density index (NDI) or orientation dispersion index (ODI) were observed in either the prefrontal cortex or hippocampus (all p-FDR ≥ 0.832). No significant associations were observed between microstructural changes and changes in cognitive function in either region (all p-FDR ≥ 0.721). At baseline, microstructure in both regions was not associated with executive function or global cognition (all p > 0.40).ConclusionThe absence of detectable microstructural changes, despite selective improvements in executive function, indicates that NODDI-derived metrics did not capture structural correlates of the cognitive response to hypoxia-cognition training. Whether this reflects functional neural mechanisms, measurement insensitivity, or the timing of the single follow-up assessment remains to be determined. Future studies should incorporate multiple imaging time points to capture the dynamic trajectories of putative microstructural brain changes.