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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromodulation Group | Experimental |
| |
| Sham Neuromodulation Group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuroelectrics StarStim 32 | Device | Using 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | An hour before and after interventions |
| 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. | An hour before and after interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before interventions |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun wei Hao, MD | Contact | 010+83198277 | haojunwei@vip.163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 10000 | China |
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| Neuroelectrics StarStim 32 | Device | Sham 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. |
|
| 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. | An hour before interventions |
| 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. | An hour before and after interventions. |
| 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. | An hour before and after interventions. |
| 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. |
| At baseline |
| 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. | At baseline |
| 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). | At baseline |
| HAMD (Hamilton Depression Rating Scale) | The HAMD is a clinician-administered scale that assesses the severity of depression symptoms. It includes 17 items that evaluate mood, behavior, and physical symptoms, such as sleep disturbances, appetite changes, and guilt. | At baseline |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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