Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (M
Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- tDCS Administration during MRI
- Remotely-supervised Daily tDCS Administration
Compared with
- Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA
Results by group
Cerebral Metabolic Rate of Oxygen (CMRO2)
Baseline Visit
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Healthy Controls | 165.84 µmol/100g/min | 25.32 (Standard Deviation) | 23 |
| MS Patients | 128.3 µmol/100g/min | 14 (Standard Deviation) | 20 |
| Healthy Control Subgroup | 159.4 µmol/100g/min | 21.8 (Standard Deviation) | 6 |
Healthy Controls
MS Patients
Healthy Control Subgroup
Cerebral Metabolic Rate of Oxygen (CMRO2)
Intermediate Visit (Month 1)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Healthy Control Subgroup | 146.42 µmol/100g/min | 27.71 (Standard Deviation) | 5 |
| MS Patients | 140.59 µmol/100g/min | 13.83 (Standard Deviation) | 20 |
Healthy Control Subgroup
MS Patients
Neuronal Reactivity (NR)
Baseline Visit (pre-tDCS, post-tDCS)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Healthy Controls | 9.84 percentage change of CMRO2 | 10.8 (Standard Deviation) | 23 |
| MS Patients | 12.45 percentage change of CMRO2 | 13.8 (Standard Deviation) | 20 |
| Healthy Control Subgroup | 15.61 percentage change of CMRO2 | 4.69 (Standard Deviation) | 5 |
Healthy Controls
MS Patients
Healthy Control Subgroup
Neuronal Reactivity (NR)
Baseline, Intermediate Visit (Month 1)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS Patients | 4.32 percentage change of CMRO2 | 8.44 (Standard Deviation) | 20 |
| Healthy Control Subgroup | 22.5 percentage change of CMRO2 | 6.88 (Standard Deviation) | 5 |
MS Patients
Healthy Control Subgroup
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Healthy Controls | 26 | 0 (0.0%) | 0 |
| MS Patients | 36 | 0 (0.0%) | 0 |
| Healthy Control Subgroup | 6 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Cerebral Metabolic Rate of Oxygen (CMRO2)
Baseline Visit
MRI lesionsCerebral Metabolic Rate of Oxygen (CMRO2)
Intermediate Visit (Month 1)
MRI lesionsNeuronal Reactivity (NR)
Baseline Visit (pre-tDCS, post-tDCS)
Neuronal Reactivity (NR)
Baseline, Intermediate Visit (Month 1)
Other measures (3)
Quality of Life in Neurological Disorders (Neuro-QOL) Score
Baseline Visit
Quality of life (reported by participants)Quality of Life in Neurological Disorders (Neuro-QOL) Score
Intermediate Visit (Month 1)
Quality of life (reported by participants)Quality of Life in Neurological Disorders (Neuro-QOL) Score
Final Visit (Month 4)
Quality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 to 79
Show the full criteria
Inclusion criteria
Inclusion Criteria for MS Patients: * Participants must be 18 years of age or older * Standardized SDMT Z-score > - 3.0 * Fatigue Severity Scale score > 36 * Definite MS diagnosis as assessed by licensed physician any subtype including Relapsing Remitting (RRMS), Primary Progressive (PPMS) or Secondary Progressive (SPMS) * Score of ≤ 7.0 on the Expanded Disability Status Scale * Clinically stable without disease progression in the past 3 months * Has stable and continuous access to internet service at home compatible with the study laptop (Wi-Fi or Ethernet cable) * Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/ * Adequate home facilities (enough space, access to quiet and distraction free area) * Able to commit to the four-week period of training sessions with baseline and two follow-up visits Exclusion Criteria for MS Patients: * Extreme claustrophobia * Relapse or steroid use in previous month * History of mental retardation, pervasive developmental disorder, or other neurological condition associated with cognitive impairment * Primary psychiatric disorder that would influence ability to participate * Current uncontrolled seizure disorder * Current substance abuse disorder * Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed) * Treatment for a communicable skin disorder currently or over the past 12 months * Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos * Pregnant or breastfeeding * Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition Scaled Score \< 85 * Beck Depression Inventory - Fast Screen (BDI-FS) score > 9 Inclusion Criteria for Healthy Controls: * Participants must be 18 years of age or older * Standardized SDMT Z-score > - 3.0 * Have not been diagnosed with MS or other neurological disorder * Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/ (HC subgroup only) * Adequate home facilities including enough space, access to quiet and distraction free area (HC subgroup only) * Able to commit to the four-week period of training sessions with baseline and one follow-up visit (HC subgroup only) Exclusion Criteria for Healthy Controls: * Extreme claustrophobia * History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment * Primary psychiatric disorder that would influence ability to participate * Current uncontrolled seizure disorder * Current substance abuse disorder * Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed) * Treatment for a communicable skin disorder currently or over the past 12 months * Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos * Pregnant or breastfeeding
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jul 2018
Main results due
Sept 2021
Finished
Sept 2021
Results posted
Jan 2024