An interventional study of rTMS in Central Pain Syndrome, sponsored by Hospital Ambroise Paré Paris. Completed at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-17.
Sponsored by Hospital Ambroise Paré Paris · Not applicable, Interventional, and Treatment
rTMS of the motor cortex is an increasingly established analgesic technique for the treatment of neuropathic pain. However its efficacy is generally modest. One reason may be the that conventional rTMS targets only superficial and small cortical regions of the human brain. A newer cooled coil, the Hesed (H) coils, now allows deep and larger surface of stimulation and has been suggested to have analgesic effects in a small pilot trial in diabetic painful polyneuropathy. Based on its deeper mechanism of action and larger surface of stimulation, we hypothesize that this technique will be more effective than rTMS in patients with central pain, a highly unmet medical need. The primary objective of the present study will be to compare the efficacy of H coil, conventional rTMS and sham stimulation of the primary motor cortex in patients central neuropathic pain. Major secondary objectives will be to directly compare the analgesic efficacy of H coil versus conventional rTMS, and compare the efficacy of both techniques in patients with lower limb pain and those with upper limb pain/face. This will be a randomized tricentric sham controlled study
This will be a tricenter randomized double blind sham controlled trial with stratified randomization based on the area of pain. Patients will first undergo MRI of the skull to determine the exact position of the coil of the motor cortex for neuronavigation with conventional rTMS. After providing informed consent, they will be randomly assigned to one of 2 treatment groups: active rTMS and Hcoil or sham rTMS and sham Hcoil, according to a 2 : 1 ratio (2 for active, 1 for placebo). For each treatment group (active or sham), the order of sessions will be again randomized according to a crossover design : thus each patient will receive successively either active rTMS followed by active H coil or active H coil followed by active rTMS or two sham stimulations (rTMS and H coil). Each treatment will be applied by an independent investigator not involved in the assessment or selection of patients. The treatment protocol will include 2 periods separated by an interval of 5 to 6 weeks depending on the potential residual analgesic effects to avoid carryover effects (patients whose pain intensity remains minimal after 6 weeks, eg less than 4 /10 on NRS, will not participate in the second crossover period of the study). Each session will consist of 5 consecutive stimulation visits of (active or sham) rTMS and H coil over 5 consecutive days. Each patient will thus receive a total of 10 stimulations (2 series of 5 active rTMS or H coil or 2 series of 5 sham rTMS or H coils) and will have a total of 15 visits, including one screening visit (V1), 10 stimulation visits (V2-V5 and V8-V13), and 4 poststimulation visits 1 and 3 weeks after each treatment period (V6, V7, V14, V15). Conventional magnetic stimulations will be applied with a MacPROX100 machine using neuronavigation system and sessions will consist of 30 series of 10 second pulses with a frequency of 10 Hz and an interval of 20 seconds between each. The stimulation intensity used will be 80 % of the resting motor threshold. Conventional rTMS stimulations will target the primary motor cortex contralateral to the painful area or left side in case of bilateral pain and sham stimulation will be carried out with the opposite face of the coil (biface coil) of identical size, color and shape emitting a sound similar to that emitted by the active coil. H-coil rTMS will be delivered with the Brainsway H-coil (Brainsway, Jerusalem, Israel) applied via a helmet placed on the head corresponding to the primary motor cortex (H10 coil) and connected to a Masgtim Rapid2 stimulatior (Mastim, Whitland, UK), while sham stimulation will be delivered with a sham coil placed in the helmet encasing the active rTMS coil. Active rTMS sessions with H-coil will use exactly the same parameters of stimulation as conventional rTMS, e.g. 30 consecutive trains of stimuli delivered at 10 Hz, at 80 % resting motor threshold (RMT), separated by intertrain intervals of 20 seconds.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 60 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Hospital Ambroise Paré Paris is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: rTMS
Device: rTMS
Conventional magnetic stimulations will be applied with a MacPROX100 machine using neuronavigation system. H-coil rTMS will be delivered with the Brainsway H-coil (Brainsway, Jerusalem, Israel) applied via a helmet placed on the head corresponding to the primary motor cortex (H10 coil) and connected to a Masgtim Rapid2 stimulatior (Mastim, Whitland, UK), while sham stimulation will be delivered with a sham coil placed in the helmet encasing the active rTMS coil. Active rTMS sessions with H-coil will use exactly the same parameters of stimulation as conventional rTMS.
Change in the self reported average pain intensity (NRS from 0 to 10) over the past 24 hours from baseline to week 3 after the end of the last stimulation
Comparison between the efficacy of sham, rTMS and H coil on average pain intensity over the course of the treatment
Time frame: the average of pain scores (NRS for pain intensity) will be conducted before each treatment for up to 3 weeks after each treatment session (treatment effect)
Score of each neuropathic dimension (ie symptom combinations) on the Neuropathic pain symptom inventory (NPSI) (Bouhassira et al 2004) .
This validated questionnaire for neuropathic pain quantifies the mean intensity of 10 neuropathic symptoms and their combination into 5 distinct dimensions during the last 24 hours on 11-point (0-10) numerical scales.
Time frame: 1 week and 3 weeks after the end of each stimulation period
proportion of responders
proportion of patients achieving at least 30 % and 50 % pain relief as compared to prestimulation values allowing to calculate Numbers Needed to Treat for 30 % and 50 % pain relief.
Time frame: 1 week and 3 weeks after the end of each stimulation period
intensity of average pain
Numerical pain scale for average pain intensity from the the Brief Pain Inventory (BPI) rated from 0 (no pain) to 10 (maximal pain imaginable)
Time frame: 1 week and 3 weeks after the end of each stimulation period
Pain interference
7 items for pain interference of the BPI rated from 0 (does not interfere), to 10 (complete interference) to measure the impact of pain on general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life
Time frame: 1 week and 3 weeks after the end of each stimulation period
Hospital Anxiety and Depression Scale (HAD)
14 items scored as anxiety and depression scores (each on 21)
Time frame: 1 week and 3 weeks after the end of each stimulation period
French version of the Pain Catastrophizing Scale (PCS)
The PCS consists of 13 items describing the thoughts and feelings that individuals may experience when in pain (range 0-52); the patients' overall impression of change (PGIC) on a 7-point scale (from very much improved to very much worse).
Time frame: 1 week and 3 weeks after the end of each stimulation period
Intensity of maximal pain over the past 24 hours
Maximal pain intensity from the Brief Pain Inventory
Time frame: 1 week and 3 weeks after the end of each stimulation period
sensory and affective score of the short form McGill Pain questionnaire
15 items, of which 11 assess the sensory dimension of pain (rated on 44) and 4 assess the affective dimension of pain (rated on 15).
Time frame: 1 week and 3 weeks after the end of each stimulation period
Intensity of least pain over the past 24 hours
Intensity of least pain on NRS from the Brief Pain Inventory
Time frame: 1 week and 3 weeks after the end of each stimulation period
intensity of brush induced allodynia
measured with a brush (SOMEDIC) (mean of 3 stimulations) in the area of maximal pain on a 0-10 NRS
Time frame: 1 week and 3 weeks after the end of each stimulation period
side effects
specific side effects questionnaire specifically designed for assessment of safety in rTMS studies
Time frame: immediately after each rTMS session
blinding
blinding questionnaire
Time frame: 3 weeks after the end of the second stimulation period
Plan to share: Undecided — No plan to make individual participant data available to other researchers
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Ambroise Paré Paris