About this trial
Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management.
Objective: To evaluate the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function among patients with inflammatory demyelinating disorders.
Methods: This study will assess cognitive performance through standardized neuropsychological assessments before and after individualized a one-time tES intervention, measuring changes in cognitive domains including working memory, attention, executive function, and processing speed.
Anticipated Results: We hypothesize that personalized transcranial electrical stimulation will demonstrate significant improvements in cognitive performance, potentially offering a non-invasive therapeutic approach for managing cognitive decline in central nervous system inflammatory demyelinating diseases.
Significance: This research may provide novel insights into neuromodulation strategies for cognitive rehabilitation in patients with complex neurological conditions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), and other Central Nervous System Inflammatory Demyelinating Diseases that meet diagnostic criteria;
Patients with SDMT scores <55 or subjective cognitive decline;
Age between 18 and 65 years, gender unrestricted;
No relapse or medication changes in the past month;
Disqualifiers
Relapse record within the past month;
Medication adjustment within the past month or having undergone modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques;
Participating in any other clinical research within 1 month prior to enrollment or currently;
Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices;
Trial design
Parallel
Treatments tested in this trial
Neuroelectrics StarStim 32
DeviceUsing the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal and parietal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session for one time with EEG monitoring conducted before and after electrical stimulation.
Neuroelectrics StarStim 32
DeviceSham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study.
Treatment groups
Trial outcomes
Primary outcomes
Working Memory Training-Related Scores
Working Memory Related Task is a widely used paradigm in cognitive psychology and neuroscience to study memory retention and recognition. In this task, participants are first presented with a image stimulus for a brief period. After a delay interval, they are shown a set of test stimuli, including the original sample and one or more distractors. The participants' task is to identify whether the sample stimulus is present among the test items. This paradigm allows researchers to investigate the effects of delay duration on memory accuracy and the neural mechanisms underlying memory encoding, maintenance, and retrieval.
SDMT (Symbol Digit Modalities Test)
The SDMT is a widely used test to measure processing speed and cognitive flexibility. Participants are asked to match symbols with corresponding numbers according to a key, which they must do as quickly as possible. This task assesses visual scanning, motor speed, and the ability to shift attention.
Secondary outcomes
AVLT (Auditory Verbal Learning Test)
The AVLT is a neuropsychological test used to assess verbal memory. It involves presenting a list of words to participants, who are then required to recall the words immediately after presentation and after a delay. The test examines both short-term and long-term verbal memory retention, as well as the ability to organize and retrieve information.
Digit Span Test
The Digit Span test measures working memory and attention. Participants are presented with a sequence of digits, and they must repeat the sequence either in the same order (forward span) or in reverse order (backward span). The test assesses both short-term memory and cognitive flexibility.
BVMTR (Brief Visual Memory Test-Revised)
The BVMTR is designed to evaluate visual memory and recognition. Participants are shown a set of geometric shapes, which they must remember. After a delay, they are asked to identify which shapes were previously shown among distractors. This test helps in assessing visual memory and the ability to recognize visual stimuli.
STROOP (Stroop Color and Word Test)
The Stroop test assesses cognitive flexibility and the ability to inhibit automatic responses. Participants are presented with words printed in different ink colors and must name the ink color rather than reading the word itself (which can be incongruent). The task evaluates cognitive control, selective attention, and response inhibition.
Other outcomes
EDSS (Expanded Disability Status Scale)
The EDSS is a scale used to measure the severity of disability in multiple sclerosis (MS) patients. It assesses both neurological impairment and physical function through a series of clinical examinations, including motor function, sensory function, coordination, and cognitive ability.
MFIS (Modified Fatigue Impact Scale)
The MFIS is a self-report questionnaire used to assess the impact of fatigue on daily functioning. It consists of questions about physical, cognitive, and psychosocial functioning, measuring how fatigue affects different areas of a person's life.
MSIS (Multiple Sclerosis Impact Scale)
The MSIS is a questionnaire designed to measure the impact of multiple sclerosis on a patient's physical and psychological well-being. It includes questions about physical disability, mobility, fatigue, and emotional well-being, providing an overall assessment of the disease's impact on quality of life.
HAMA (Hamilton Anxiety Rating Scale)
The HAMA is a clinician-administered scale used to assess the severity of a patient's anxiety. It includes 14 items that evaluate both psychological and physical symptoms of anxiety, such as tension, fear, and physiological symptoms (e.g., palpitations).
Sponsors and contacts
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