Trial · NCT05811013
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Functional assessment, that "change" is being assessed. | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | The primary aim the project is to evaluate the effect of tSMS in ambulatory patients with PMS with ascending myelopathy phenotype (from now on, simply called PMS) on clinical severity, assessed through the three components of the Multiple Sclerosis Functional Composite (MSFC). |
| Secondary | Neurological Assessment, that "change" is being assessed. | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Clinical severity will be assessed through the Expanded Disability Status Scale (EDSS). |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Verbal episodic long-term memory will be evaluated with the Selective Reminding Test as LongTerm Storage (SeRT-LTS). |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Verbal episodic long-term memory will be evaluated with the Consistent Long Term Retreival (SeRT-CLTR). |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Verbal episodic long-term memory will be evaluated with the Delayed Recall (SeRT-DR). |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Visuos patial episodic long-term memory will be evaluated with the Delayed Recall of Rey's Complex Figure (RCF- DR). |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Executive functions and attention will be evaluated with Word List Generation (WLG). |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Executive functions and attention will be evaluated with Symbol Digit Modalities Test (SDMT). |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Executive functions and attention will be evaluated with Paced Auditory Serial Addition Test (PASAT). |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Executive functions and attention will be evaluated with Stroop Test interference both in terms of errors (ST-E) |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Executive functions and attention will be evaluated with response time (ST-RT) |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Executive functions and attention will be evaluated with Brief Visuospatial Memory Test (BVMT) |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Praxis ability will be evaluated with the Copy of Rey's Complex. |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Anxiety will be assessed by State-Trait Anxiety Inventory form Y (STAI-Y) |
| Secondary | Neuropsychological and psychometric evaluation | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Depression will be assessed with the Beck Depression Inventory-Second Edition (BDI-II). |
| Secondary | Neurophysiological assessment | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Transcranial magnetic stimulation will be delivered with Magstim 2002 magnetic stimulators or with a Magstim Rapid2 stimulator (The Magstim Company, Whitland, Dyfed, UK). The stimulators will be connected to a figure-of-eight coil (external wing diameter 70 mm) placed tangentially over the scalp with the handle pointing back and away from the midline at about 45°, in the optimal position for eliciting motor evoked potentials (MEPs) in the first dorsal interosseous (FDI) muscle of the dominant hand. Electromyographic signals will be recorded with surface electrodes placed on the target muscle, sampled at 5 KHz with a CED 1401 A/D laboratory interface (Cambridge Electronic Design, Cambridge, UK), and amplified and filtered (bandpass 20 Hz to 2 kHz) with a Digitimer D360 amplifier (Digitimer Ltd, Welwyn Garden City, Hertfordshire, UK), then recorded by a computer with Signal software (Cambridge Electronic Design). Motor thresholds will be calculated at rest (RMT) as the lowest stimul |
| Secondary | blood neurofilament light chain (NFL) levels | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Measures of NfL will be prospectively performed in the laboratory of Dr. Roberto Furlan (IRCCS San Raffaele, Milan). As a specific marker of neuroaxonal degeneration, increasing serum levels of NfL are seen in patients with a higher degree of disability independently of ongoing relapses (Bjornevik et al., 2020). Together with the medium and heavy subunits, NfL represents one of the scaffolding proteins of the neuronal cytoskeleton and is released in the extracellular space following axonal damage (Teunissen CE, Khalil M. 2012). The levels of serum sNfL, are a sensitive biomarker of ongoing neuroaxonal degeneration and represent a sensitive and clinically meaningful blood biomarker to monitor tissue damage and the effects of therapies in MS (Di Santo et al., 2017). |
| Secondary | Magnetic Resonance Imaging (MRI) | BASELINE EVALUATION 1-30 DAYS BEFORE REAL OR SHAM tSMS T0; 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | Cortical thickness and T2 lesion load will be analyzed by using the 3T MR scanner (GE Signa HDxt, GE Healthcare, Milwaukee, Wisconsin). Will be used a 3D Spoiled Gradient Recalled (SPGR) T1-weighted sequence (178 contiguous sagittal slices, voxel size 1×1×1 mm, TR 7 ms, TE 2.856 ms, Inversion Time 450 ms) and a 3D FLAIR sequence (208 contiguous sagittal 1.6 mm slices, voxel size, 0.8 × 0.8 × 0.8 mm, TR 6000 ms, TE 139.45 ms; Inversion Time 1827 ms). White matter lesions will be segmented from FLAIR and T1 images by using the lesion growth algorithm as implemented in version 2.0.15 of the lesion segmentation tool (www.statistical-modelling.de/lst.html) for SPM12 (https://www.fl.ion.ucl.ac.uk/spm). Furthermore, the computational anatomy toolbox (CAT12, version 916, https://dbm.neuro.uni-jena.de/cat/) as implemented in SPM12 will be used to extract individual cortical thickness values from lesion-filled MR images. Finally, T2 lesion load will be computed from 3D T1 and 3d FLAIR images by |
| Secondary | Patients' adherence to tSMS, potential side effects and adverse events | 6 MONTHS OF STIMULATION (SESSION 1, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 1, T12); 6 MONTHS OF STIMULATION (SESSION 2, T6); 1-30 DAYS AFTER THE END OF STIMULATION (SESSION 2, T12) | The number of completed stimulation sessions will be recorded daily by each patient and/or the caregiver during the periods of self-administered tSMS treatment. Patients will fill a diary in which they will be instructed to record the following data: likert scale on sleep quality, presence of headache, treatment compliance. Potential side effects and adverse events will be reported by patients to the referring physician. If necessary, further clinical evaluations will be scheduled. At each timepoint, compliance will be assessed according to the following criteria: * "fully compliant" if he/she has performed at least 80% of the planned sessions of stimulation, * "moderately compliant" if he/she has performed between 50% and 80% of the treatment sessions, * "poor -compliant" if he/she has performed \<50% of the treatment sessions. Caregivers will be instructed to monitor and favor treatment adherence. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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