Essential Head Tremor Clinical Trial
— Btx-HTOfficial title:
Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor by a Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study
| Verified date | December 2022 |
| Source | University Hospital, Clermont-Ferrand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Essential head tremor (HT) does not usually respond to drug treatment such as propranolol or primidone or to surgical treatment such as deep brain stimulation of the thalamic ventralis intermedius nucleus. Botulinum toxin (Btx) is widely used and efficient in the treatment of blepharospasm and cervical dystonia. Btx prevents the release of acetylcholine in synapses, leading to a reduction of pathological muscle movement. Very little information is available on its efficacy on HT. Two published reports suggested that local Btx A injections could be an effective and safe approach for treating HT. Given the scarcity of published data (small samples, open studies, different doses of Btx used, heterogeneous populations, several muscles injected, etc.), the aim of this study is to demonstrate the efficacy of Btx injections in essential HT by a multi-center, randomized, double-blind, parallel-group, placebo-controlled study. Principal objective: To evaluate the efficacy of botulinum toxin injections in the treatment of head tremor. Secondary objectives: - - To evaluate the tolerance of botulinum toxin injections in the treatment of head tremor. - - To evaluate the impact of botulinum toxin injections on the patients' quality of life and embarrassment. - To evaluate the changes of tremor characteristics induced by a Btx treatment using a 3D accelerometer wireless portable system (Xsens MTw wireless motion tracker system) (tremor frequency, tremor displacement, mean peak amplitude, distance traveled) and a new video system device to analyze head tremor characteristics
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | September 1, 2022 |
| Est. primary completion date | September 17, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Patients suffering from a head tremor without (isolated) or with associated - tremor in any other body parts. - The HT must be troublesome for the patients (TRS 2 for the head tremor - severity item). - Patients never treated with botulinum toxin or not treated with botulinum toxin for this indication for at least 4 months. - Men or women aged from 18 to 80 years old. - Social security coverage. - Ability to provide informed consent. Exclusion Criteria: - Patients with tremor from cerebellar syndrome (multiple sclerosis, etc.). - Patients with a predominant dystonic jerky or myoclonic head tremor using - the Tsui scale (>1). - Oral treatments for HT are allowed but must be stable during the study. - Any contra-indication to Botulinum toxin. - Women without efficient contraception. - Patients under supervision or (legal) guardianship. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Pays D'Aix | Aix-en-Provence | |
| France | CHU d'Amiens | Amiens | |
| France | Hôpital Jean Minjoz | Besançon | |
| France | Hôpital Haut-Levêque | Bordeaux | |
| France | CHU de Clermont-Ferrand | Clermont-Ferrand | |
| France | Hôpital R Salendro | Lille | |
| France | Hôpital neurologique | Lyon | |
| France | Hôpital de la Timone | Marseille | |
| France | CH Narbonne | Narbonne | |
| France | Hôpital Caremeau | Nîmes | |
| France | AP-HP | Paris | |
| France | Fondation Rothschild | Paris | |
| France | Hopital Lariboisière | Paris | |
| France | Hôptal Avicenne de Bobigny | Paris | |
| France | CHU de Poitiers | Poitiers | |
| France | Hôpital de Hautepierre | Strasbourg | |
| France | CHU de Toulouse | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand | Allergan |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical state improvement of patients evaluated by the Clinical Global Impression of Change (CGI) | clinical state improvement of patients evaluated by the Clinical Global Impression of Change (CGI) (improvement by at least two points) measured 6 weeks after the 2nd injection of Btx (at 18W). | at 18 weeks | |
| Primary | % of responders defined with CGI | at 6 weeks | ||
| Primary | % of responders defined with CGI | at 18 weeks | ||
| Primary | The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head) | at day 0 | ||
| Primary | The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head) | at 6 weeks | ||
| Primary | The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head) | at 12 weeks | ||
| Secondary | The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head) | at 18 weeks | ||
| Secondary | The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head) | at 24 weeks | ||
| Secondary | The Essential Tremor Embarrassment Assessment (ETEA) | at day 0 | ||
| Secondary | The Essential Tremor Embarrassment Assessment (ETEA) | at 6 weeks | ||
| Secondary | The Essential Tremor Embarrassment Assessment (ETEA) | at 12 weeks | ||
| Secondary | The Essential Tremor Embarrassment Assessment (ETEA) | at 18 weeks | ||
| Secondary | The Essential Tremor Embarrassment Assessment (ETEA) | at 24 weeks | ||
| Secondary | The Quality of life in Essential Tremor (QUEST) | at day 0 | ||
| Secondary | The Quality of life in Essential Tremor (QUEST) | at 6 weeks | ||
| Secondary | The Quality of life in Essential Tremor (QUEST) | at 12 weeks | ||
| Secondary | The Quality of life in Essential Tremor (QUEST) | at 18 weeks | ||
| Secondary | The Quality of life in Essential Tremor (QUEST) | at 24 weeks | ||
| Secondary | tremor frequency measured by accelerometer | at day 0 | ||
| Secondary | tremor frequency measured by accelerometer | at 6 weeks | ||
| Secondary | tremor frequency measured by accelerometer | at 12 weeks | ||
| Secondary | tremor frequency measured by accelerometer | at 18 weeks | ||
| Secondary | tremor frequency measured by accelerometer | at 24 weeks | ||
| Secondary | mean peak amplitude measured by accelerometer | at day 0 | ||
| Secondary | mean peak amplitude measured by accelerometer | at 6 weeks | ||
| Secondary | mean peak amplitude measured by accelerometer | at 12 weeks | ||
| Secondary | mean peak amplitude measured by accelerometer | at 18 weeks | ||
| Secondary | mean peak amplitude measured by accelerometer | at 24 weeks | ||
| Secondary | distance traveled measured by accelerometer | at day 0 | ||
| Secondary | distance traveled measured by accelerometer | at 6 weeks | ||
| Secondary | distance traveled measured by accelerometer | at 12 weeks | ||
| Secondary | distance traveled measured by accelerometer | at 18 weeks | ||
| Secondary | distance traveled measured by accelerometer | at 24 weeks |