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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02045-50 | Registry Identifier | ID-RCB |
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Botulinum toxin injections are the treatment of choice for cervical dystonia. Even if this treatment is successful for most of the patients, partials or completes failures still remained.
Usually, botulinum toxin injections are realized by clinical localization techniques (observation and palpation of target muscles). The use of Ultrasonography to guide injections of Botulinum toxin has theoretical benefits (as an improved precision, an improved reproducibility, the targeting of deep-seated muscles, and a lower risk of adverse events) but its interest has never been demonstrated.
Open label non-randomised controlled clinical trial comparing clinical localization techniques and ultrasonography to guide injections of Botulinum toxin A.
The primary outcome is to compare both techniques of injection regarding to the health impact of cervical dystonia (CDIP-58) measured 1 month after injection.
The results of this clinical trial will help the clinician to decide which strategy of injection is the most effective in terms of benefit/risk ratio to treat the cervical dystonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical targeting | Experimental | Clinical localization method (observation and palpation of target muscles) |
|
| Ultrasonography targeting | Experimental | Ultrason-guided method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical targeting | Procedure | The intervention consists of the injection of botulinum toxin A into muscles targeted by a clinical localization method (observation and palpation of target muscles) |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Dystonia Impact Profile 58 (CDIP-58) | Variation of the total score obtained with The Cervical Dystonia Impact Profile | 1 month after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Placement of the injecting needle | Assessment of the accurate placement of the injecting needle within the target muscle by ultrasonography in patients injected by the clinical targeting method (number and percent of discordances) | the day of the inclusion |
| GCI-I (Clinical Global Impressions - Improvement) patient scale |
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Inclusion Criteria:
Exclusion Criteria:
Woman pregnant, woman of childbearing age not taking effective contraception or breastfeeding
Contraindication of botulinum toxin injections as :
Concomitant treatment that can interact with botulinum toxin A or modify the function of the neuromuscular synapse junction (anticholinergics, curare and other myorelaxing agents, Aminoglycosides, amino-4-quinolines)
Documented resistance to the botulinum toxin A
Inability to receive the information, inability to participate to the all study duration, refusal to sign the consent
EMG-guided botulinum toxin injections
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre KREISLER, MD, Ph | Hôpital Roger Salengro, CHRU Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Ultrasonography targeting | Procedure | The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method |
|
Variation of the GCI-I (Clinical Global Impressions - Improvement) patient scale :
|
| 1 month after inclusion |
| TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only | Variation of the TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only Total score = 0 (no pain) to 40 (maximal pain) | 1 month after inclusion |
| TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale | Variation of the TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale Total score = 0 (no psychiatric disorders) to 24 (important psychiatric disorders) | 1 month after inclusion |
| Rate of Adverse Events | Adverse events related to the botulinum toxin injection (pain, swallowing disorders, hematoma, muscular weakness, dry mouth) | 1 month after inclusion |
| D013568 |
| Pathological Conditions, Signs and Symptoms |