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AlgoneurodystrophyALGOSTIMNCT02817880

Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy.

A study testing rTMS, tDCS and tsDCS in people with Algoneurodystrophy, run by University Hospital, Grenoble at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the algoneurodystrophy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Algoneurodystrophy
What is being tested?
rTMS, tDCS and tsDCS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesFrance
Study dates
25 Jul 2016to 22 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient's written consent
  • Patient suffering from an algoneurodystrophy for more than a year.
  • Diagnosis of algoneurodystrophy confirmed by an osseous scintigraphy
  • Stable treatment for at least 1 month
  • Patient non-responsive to pharmacological treatments
  • VNS > 3 at the time of screening

Who cannot join

  • Drug addiction
  • History of epilepsy, head trauma, Psychiatric pathology likely to hamper the progress of the study.
  • Intracranial ferromagnetic material or an implanted stimulator
  • MRI contraindication
  • Algoneurodystrophy due to a nervous lesion
  • Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor

    Créteil, Île-de-France Region, 94010

  • Centre de la douleur, CHU Grenoble Alpes

    Grenoble, Isere, 38043

Other trials in France

About this study

Official title: Comparison of the Analgesic Effect Between the Motor Cortex Stimulation (tDCS and rTMS) and the Trans-spinal Stimulation (tsDCS ) in the Algoneurodystrophy of Members. A Randomised Clinical Trial. tDCS : Transcranial Direct-current Stimulation rTMS : Repetitive Transcranial Magnetic Stimulation tsDCS : Transcutaneous Spinal Direct Current Stimulation

The purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the algoneurodystrophy.

Read the detailed description
  • Entry into the study : After informed consent, patients will be randomised into three groups : tDCS, rTMS, tsDCS. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS).
  • Baseline : Participants, will record on a book, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 month.
  • The beginning of the treatment : after the baseline, sessions of neurostimulation will begin. Sessions of neurostimulation will have a decreasing rhythm. Five sessions per week during the two first weeks, two sessions per week during the third week, one session during the fourth week and then two sessions per month for four months.
  • After the end of neurostimulation sessions, patients will be followed for 1month.

Throughout their participation in the study, patients will complete their VNS report book (1month of baseline before the treatment, 3 months during neurostimulation, 1 month after neurostimulation).

Patients will have 5 evaluation examinations:

  • The first, one just before the beginning of the neurostimulation,
  • The second, 1 month after the beginning of neurostimulation
  • The third, 3 months after the beginning of neurostimulation
  • And the last one, 1 month after the end of neurostimulation.
Being tested
rTMS, tDCS, tsDCS
Keywords
rTMS, tDCS, tsDCS, pain, algoneurodystrophy , neurostimulation
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMSDevice

  • tDCSDevice

  • tsDCSDevice

Study groups in NCT02817880
Study groupRoleWhat they receive
rTMS (repetitive transcranial magnetic stimulation)ExperimentalrTMS (repetitive transcranial magnetic stimulation)
Receives: Device: rTMS
tDCS (transcranial direct-current stimulation)ExperimentaltDCS (transcranial direct-current stimulation)
Receives: Device: tDCS
tsDCS (transcutaneous spinal Direct Current Stimulation)ExperimentaltsDCS (transcutaneous spinal Direct Current Stimulation)
Receives: Device: tsDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Visual numeric scale of pain between the three groups

    Measured: Baseline to 1 month

Secondary outcomes (6)

  1. The Clinical Global Impression scale (CGI) between the three groups

    Measured: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)

  2. The SF12 quality of life questionnaire between the three groups

    Measured: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)

  3. The Hospital Anxiety and Depression scale (HAD) between the three groups

    Measured: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)

  4. The Neuropathic Pain Symptom Inventory scale (NPSI) between the three groups

    Measured: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)

  5. Evolution of the conductance of feet and hands by using Sudoscan

    The body conductance will be used to assess the evolution of the Impact of the neurostimulation on the sympathetic nervous system and on the small fiber neuropathy.

    Measured: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)

  6. Modifications of the sensori-motor cortical cards by using a MRI

    Measured: Baseline, and 1 month after the end of the treatment (Day 180)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study start25 Jul 2016
  3. Primary completion11 Jun 2021
  4. Study completion22 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817880
Sponsor's protocol ID
38RC15.158
Acronym
ALGOSTIM
Status last verified
May 2022
First submitted
27 Jun 2016
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Keravel Y, Nguyen JP. Motor cortex rTMS restores defective intracortical inhibition in chronic neuropathic pain. Neurology. 2006 Nov 14;67(9):1568-74. doi: 10.1212/01.wnl.0000242731.10074.3c.

    PubMed 17101886

  • de Andrade DC, Mhalla A, Adam F, Texeira MJ, Bouhassira D. Neuropharmacological basis of rTMS-induced analgesia: the role of endogenous opioids. Pain. 2011 Feb;152(2):320-326. doi: 10.1016/j.pain.2010.10.032. Epub 2010 Dec 10.

    PubMed 21146300

  • Lefaucheur JP, Andre-Obadia N, Poulet E, Devanne H, Haffen E, Londero A, Cretin B, Leroi AM, Radtchenko A, Saba G, Thai-Van H, Litre CF, Vercueil L, Bouhassira D, Ayache SS, Farhat WH, Zouari HG, Mylius V, Nicolier M, Garcia-Larrea L. [French guidelines on the use of repetitive transcranial magnetic stimulation (rTMS): safety and therapeutic indications]. Neurophysiol Clin. 2011 Dec;41(5-6):221-95. doi: 10.1016/j.neucli.2011.10.062. Epub 2011 Nov 10. French.

    PubMed 22153574

  • Lefaucheur JP, Menard-Lefaucheur I, Goujon C, Keravel Y, Nguyen JP. Predictive value of rTMS in the identification of responders to epidural motor cortex stimulation therapy for pain. J Pain. 2011 Oct;12(10):1102-11. doi: 10.1016/j.jpain.2011.05.004. Epub 2011 Jul 31.

    PubMed 21807565

  • Lefaucheur, J. P. (2007).

  • Khedr EM, Kotb H, Kamel NF, Ahmed MA, Sadek R, Rothwell JC. Longlasting antalgic effects of daily sessions of repetitive transcranial magnetic stimulation in central and peripheral neuropathic pain. J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):833-8. doi: 10.1136/jnnp.2004.055806.

    PubMed 15897507

  • Passard A, Attal N, Benadhira R, Brasseur L, Saba G, Sichere P, Perrot S, Januel D, Bouhassira D. Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. Brain. 2007 Oct;130(Pt 10):2661-70. doi: 10.1093/brain/awm189. Epub 2007 Sep 14.

    PubMed 17872930

  • Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.

    PubMed 25034472

  • Leung A, Donohue M, Xu R, Lee R, Lefaucheur JP, Khedr EM, Saitoh Y, Andre-Obadia N, Rollnik J, Wallace M, Chen R. rTMS for suppressing neuropathic pain: a meta-analysis. J Pain. 2009 Dec;10(12):1205-16. doi: 10.1016/j.jpain.2009.03.010. Epub 2009 May 23.

    PubMed 19464959

  • Lefaucheur JP. Use of repetitive transcranial magnetic stimulation in pain relief. Expert Rev Neurother. 2008 May;8(5):799-808. doi: 10.1586/14737175.8.5.799.

    PubMed 18457536

  • Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.

    PubMed 14580622

  • Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.

    PubMed 11723286

  • Medeiros LF, de Souza IC, Vidor LP, de Souza A, Deitos A, Volz MS, Fregni F, Caumo W, Torres IL. Neurobiological effects of transcranial direct current stimulation: a review. Front Psychiatry. 2012 Dec 28;3:110. doi: 10.3389/fpsyt.2012.00110. eCollection 2012.

    PubMed 23293607

  • Thibaut A, Chatelle C, Gosseries O, Laureys S, Bruno MA. [Transcranial direct current stimulation: a new tool for neurostimulation]. Rev Neurol (Paris). 2013 Feb;169(2):108-20. doi: 10.1016/j.neurol.2012.05.008. Epub 2012 Sep 7. French.

    PubMed 22959705

  • Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.

    PubMed 17133529

Questions about this trial

What is this clinical trial studying?

A study testing rTMS, tDCS and tsDCS in people with Algoneurodystrophy, run by University Hospital, Grenoble at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Visual numeric scale of pain between the three groups (time frame: Baseline to 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02817880, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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