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

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ClinicalTrials.gov Identifier: NCT02817880
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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.

Condition or disease Intervention/treatment Phase
Algoneurodystrophy Device: rTMS Device: tDCS Device: tsDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 25, 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rTMS (repetitive transcranial magnetic stimulation)
rTMS (repetitive transcranial magnetic stimulation)
Device: rTMS
Experimental: tDCS (transcranial direct-current stimulation)
tDCS (transcranial direct-current stimulation)
Device: tDCS
Experimental: tsDCS (transcutaneous spinal Direct Current Stimulation)
tsDCS (transcutaneous spinal Direct Current Stimulation)
Device: tsDCS



Primary Outcome Measures :
  1. The Visual numeric scale of pain between the three groups [ Time Frame: Baseline to 1 month ]

Secondary Outcome Measures :
  1. The Clinical Global Impression scale (CGI) between the three groups [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) ]
    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.

  6. Modifications of the sensori-motor cortical cards by using a MRI [ Time Frame: Baseline, and 1 month after the end of the treatment (Day 180) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817880


Contacts
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Contact: HASAN HODAJ, MD 0476765213 ext +33 HHodaj@chu-grenoble.fr

Locations
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France
Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor Recruiting
Créteil, Ile De France, France, 94010
Contact: Jean-Pascal LEFAUCHEUR, MD-PHD         
Centre de la douleur, CHU Grenoble Alpes Recruiting
Grenoble, Isere, France, 38043
Contact: Hasan HODAJ, MD    0476765213 ext +33    HHodaj@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble

Additional Information:
Publications:
Lefaucheur, J. P. (2007).
M. Sorel, J.-P. Lefaucheur, J.-C. Beatrix, A.M. Domec, M.L. Giboutet, E. Houy, J. Robert, P. Cesaro (2012); Complex regional pain syndrome: interest in coupling the vascular phase of technetium 99 bone scintigraphy with the effectiveness of ketamine. Lett. Méd. Phys. Réadapt., OI 10.1007/s11659-012-0296-1

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02817880     History of Changes
Other Study ID Numbers: 38RC15.158
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
rTMS, tDCS, tsDCS, pain, algoneurodystrophy , neurostimulation

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs