Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET)
Completed · Not applicable · Has a placebo group
Conditions studied: Essential Tremor
In brief
To compare the efficacy of botulinum toxin (BoNT) injections in forearm flexors plus extensor muscles versus flexors alone for the treatment of essential hand tremor (ET).
Key facts
- Study ID
- NCT02909907
- Run by
- The Cleveland Clinic
- People needed
- 21
- Starts
- 2016-08-01
- Expected to finish
- 2018-02-28
- Last updated by the study team
- 2019-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 and over, male or female patient with (ET) involving at least their dominant hand, as diagnosed by a movement disorders neurologist.
- Having bothersome hand tremor in dominant hand with a hand TRS ≥2
- On stable medications during last 30 days prior to enrollment.
You may not qualify if…
- Presence of secondary causes of tremor, such as dystonia and parkinsonism
- Any contraindication to botulinum toxin injections (e.g. motor neuron disease, neuromuscular junction disease, etc.)
- History of surgical treatment for (ET).
- Dementia as defined by DSM-V criteria
- Patients with suboptimally treated depression and significant depressive symptoms as defined by a PHQ-9 score of ≥15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression). Antidepressant medications, prescribed for depression or anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
- Patients with suboptimally treated anxiety and significant anxiety symptoms as defined by a GAD-7 score of ≥15 (GAD-7 scores 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety). Anti-anxiety medications, prescribed for anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
- Significant renal, hepatic, cardiac and thyroid disease
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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