Transcranial Direct Current Stimulation to Lower Neuropathic Pain in P
Transcranial Direct Current Stimulation to Lower Neuropathic Pain in People With Multiple Sclerosis: a Mechanistic FDG-PET Study
What it found
The trial ended early for another reason (see below).
Reason given: Principal Investigator is taking appointment with another institution.
What was tested
Treatment tested
- Active tDCS using tDCS device
Placebo
- SHAM tDCS using tDCS device
Results by group
Cerebral Glucose Uptake in Patients With Multiple Sclerosis With Neuropathic Pain
1 week
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Active tDCS With a tDCS Device | 3 percentage of glucose uptake increase | 0 (Standard Deviation) | 1 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Active tDCS With a tDCS Device | 1 | 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 Glucose Uptake in Patients With Multiple Sclerosis With Neuropathic Pain
1 week
Pain
Other measures (2)
Change in Neuropathic Pain as Recorded on a Visual Analog Scale (VAS).
1 week
PainChange in Neuropathic Symptom Inventory
1 week
Pain
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion criteria
* Patients with Multiple Sclerosis (PwMS) * Age range 18-65 * Expanded disability status scale comprised between 1.5 and 6.5 with relapsing remitting MS (RRMS) in remitting phase * Presenting with chronic, drug-resistant, neuropathic pain * Patients must score at or above a 0 on the Neuropathic Pain Questionnaire (NPQ). * Patients must score at least a 40 mm on the visual analog scale (VAS) for pain perception at baseline * All analgesic medications discontinued at least 24 hours before entering the study
Exclusion criteria
* Any change in: * disease-modifying medications, or * a relapse of disease symptoms within the last 60 days * History of seizures * History of traumatic brain injury * History of claustrophobia * Presence of: * pacemakers, * aneurysm clips, * artificial heart valves, * metallic prostheses, or * pregnancy. * Recent hospitalization (within the last 3 months) * Enforced bed rest/sedentary state * Resting plasma glucose greater than 200 mg/dl * Presence of other neurological disorders.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Transcranial Direct Current Stimulation (tDCS) is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to apply currents to the brain and modulate the level of cortical excitability. tDCS applied over the dorsolateral prefrontal and motor cortex has been reported to be able to decrease pain sensation and to increase pain threshold in healthy subjects and is effective in reducing central chronic pain in patients with multiple sclerosis (PwMS.) In spite of the encouraging results of tDCS in PwMS, detailed mechanisms accounting for its analgesic effect have not yet been elucidated. This will be the first study to determine the effects of tDCS on whole and regional brain activity in PwMS with neuropathic pain to identify potential mechanisms of the analgesic effects of tDCS. These findings will provide targets for future studies investigating different stimulation areas, possible short- and long-term side effects, and specific target areas for other precise stimulation techniques such as transcranial magnetic stimulation.
Loading reviews and guidelines…
History
Started
Feb 2018
Main results due
Jun 2018
Finished
Jul 2018
Results posted
Nov 2022