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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02471066 |
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Date of registration:
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10/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy
MOVHYSTIM |
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Scientific title:
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Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Functional Psychogenic Movement Disorders Followed by a Feasibility Study of a Hypnotherapy Treatment as Adjuvant Therapy. |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02471066 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Man or woman with FNPMD for at least 2 months,
- diagnosed from clinical Diagnostic and Statistical Manual V conversive somatoform
troubles and Gupta & Lang (2009) and Edwards & Bahtia 2012 neurological clinical
criteria
Exclusion criteria:
- Severe progressive psychiatric disorders
- Cardiac pace-maker
- Metallic prosthesis
- Cochlear implants
- Previous neurosurgery
- Epilepsy
- Severe cardiac disease
- Alcohol or toxic abuse for the last 12 months
- Drugs such clozapine, bupropion, methadone or theophylline
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Movement Disorders
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Intervention(s)
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Device: rTMS
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Primary Outcome(s)
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Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment
[Time Frame: Inclusion and 1 month later]
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Secondary Outcome(s)
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Quality of Life (SF-36)
[Time Frame: inclusion, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.]
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Clinical Global Impression-Severity scale (CGI-SEVERITY/CGI-I/CGI-S)
[Time Frame: inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.]
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Hospital Anxiety and Depression Scale (HAD/HDRS)
[Time Frame: inclusion, inclusion + 1 month, inclusion + 6 months, inclusion + 12 months.]
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Pain scale (VAS)
[Time Frame: : inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.]
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Temperament and Character Inventory (TCI)
[Time Frame: inclusion, inclusion + 12 months.]
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Secondary ID(s)
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14 7311 02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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