Last reviewed · How we verify
Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
NA trial testing tDCS Administration during MRI in Multiple Sclerosis in 73 participants. Completed in 29 September 2021.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 73 |
| Start date | 9 July 2018 |
| Primary completion | 29 September 2021 |
| Estimated completion | 29 September 2021 |
| Sites | 1 location across United States |
NYU Langone Health — full company profile →
Adults 18 to 79, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
| Group | Value | 95% CI |
|---|---|---|
| Healthy Controls | 165.84 | ± 25.32 |
| MS Patients | 128.3 | ± 14 |
| Healthy Control Subgroup | 159.4 | ± 21.8 |
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
| Group | Value | 95% CI |
|---|---|---|
| Healthy Control Subgroup | 146.42 | ± 27.71 |
| MS Patients | 140.59 | ± 13.83 |
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS. tDCS will be administered in one visit and will last for approximately 15 minutes.
| Group | Value | 95% CI |
|---|---|---|
| Healthy Controls | 9.84 | ± 10.8 |
| MS Patients | 12.45 | ± 13.8 |
| Healthy Control Subgroup | 15.61 | ± 4.69 |
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS.
| Group | Value | 95% CI |
|---|---|---|
| MS Patients | 4.32 | ± 8.44 |
| Healthy Control Subgroup | 22.5 | ± 6.88 |
36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.
| Group | Value | 95% CI |
|---|---|---|
| MS Patients | 50.81 | ± 13.04 |
36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.
| Group | Value | 95% CI |
|---|---|---|
| MS Patients | 36.38 | ± 13.16 |
36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.
| Group | Value | 95% CI |
|---|---|---|
| MS Patients | 39.12 | ± 12.65 |
Time frame: 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Healthy Controls | MS Patients | Healthy Control Subgroup |
|---|---|---|---|---|
| Tingling | Skin and subcutaneous tissue disorders | — | — | — |
| Warmth Sensation under the electrode | Skin and subcutaneous tissue disorders | — | — | — |
| Itching | Skin and subcutaneous tissue disorders | — | — | — |
Data from ClinicalTrials.gov NCT03564496 adverse events section.
The objective of this trial is to measure the changes in neural activities during tDCS session using Magnetic Resonance Imaging (MRI). Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. multiple sclerosis) will be recruited to complete self-report measures and a brief cognitive assessment and then undergo an hour long stand-alone MRI scan while simultaneously undergoing tDCS stimulation. Methodology for this study is the administration of 15-minutes of of active tDCS during MRI acquisition compared to time without active tDCS.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03564496.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing