Multiple SclerosisNCT06968039
Effectiveness of Personalized Alternating Current Stimulation for Treating Cognitive Impairment in CNS Demyelination Patients
A study testing Neuroelectrics StarStim 32 in people with Multiple Sclerosis and Electric Stimulation, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Electric Stimulation
- What is being tested?
- Neuroelectrics StarStim 32
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- EDSS (Expanded Disability Status Scale) score ≤6;
- Right-handed, native Chinese speakers with sufficient educational background to understand the test instructions; -Willing to participate and have signed informed consent.-
Who cannot join
- 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;
- Skin integrity damage at electrode placement sites, or allergy to electrode gel or adhesives;
- History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections;
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- Pregnant or lactating women, or those planning pregnancy in the near future;
- Scoring ≥3 on item 3 (suicide item) of the HDRS-17 or concurrent severe mental illness;
- Concurrent severe or unstable organic diseases;
- Unable to cooperate with treatment, follow-up, or clinical, EEG, and imaging data collection due to poor patient compliance;
- Other situations deemed inappropriate for study participation by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 10000
Junwei Hao, MD, 010+83198277, haojunwei@vip.163.com
About this study
Official title: This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Working Memory in Patients With Inflammatory Demyelination of the Central Nervous System
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.
Read more
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.
- Conditions
- Multiple Sclerosis, Electric Stimulation
- Being tested
- Neuroelectrics StarStim 32
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroelectrics StarStim 32Device
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.
Neuroelectrics StarStim 32Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation Group | Experimental | Not described Receives: Device: Neuroelectrics StarStim 32 |
| Sham Neuromodulation Group | Sham comparator | Not described Receives: Device: Neuroelectrics StarStim 32 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: An hour before and after interventions.
Secondary outcomes (4)
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.
Measured: Before interventions
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.
Measured: 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.
Measured: 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.
Measured: An hour before and after interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start31 Dec 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968039
- Sponsor's protocol ID
- xw-tES-04
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Working Memory in Patients With Inflammatory Demyelination of the Central Nervous System
- ClinicalTrials.gov ID
- NCT06968039
- Acronym / sponsor ID
- xw-tES-04
- Conditions
- Multiple Sclerosis, Electric Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation Group | Experimental | Device: Neuroelectrics StarStim 32 |
| Sham Neuromodulation Group | Sham comparator | Device: Neuroelectrics StarStim 32 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- EDSS (Expanded Disability Status Scale) score ≤6;
Key exclusion criteria (11 listed)
- 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;
- Skin integrity damage at electrode placement sites, or allergy to electrode gel or adhesives;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroelectrics StarStim 32Using 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. | Device | Neuromodulation Group |
| Neuroelectrics StarStim 32Sham 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. | Device | Sham Neuromodulation Group |
Primary outcome
Working Memory Training-Related Scores
Time frame: An hour before and after interventions
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)
Time frame: An hour before and after interventions.
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.
4 secondary outcomes
AVLT (Auditory Verbal Learning Test)
Time frame: Before interventions
Digit Span Test
Time frame: An hour before interventions
BVMTR (Brief Visual Memory Test-Revised)
Time frame: An hour before and after interventions.
STROOP (Stroop Color and Word Test)
Time frame: An hour before and after interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroelectrics StarStim 32 in people with Multiple Sclerosis and Electric Stimulation, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun wei Hao, MD (010+83198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working Memory Training-Related Scores (time frame: An hour before and after interventions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.