Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET) (FLEX-D ET)

April 24, 2019 updated by: The Cleveland Clinic

Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles Versus Flexor Muscles Alone for the Treatment of Essential Hand Tremor (FLEX-D ET)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators propose a pilot, single center, double blind, randomized, parallel, placebo controlled trial comparing 2 (BoNT) injection patterns for treatment of moderate to severe essential tremor. The investigators will recruit 20 patients with (ET).

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 and over, male or female patient with (ET) involving at least their dominant hand, as diagnosed by a movement disorders neurologist.
  2. Having bothersome hand tremor in dominant hand with a hand TRS ≥2
  3. On stable medications during last 30 days prior to enrollment.

Exclusion Criteria:

  1. Presence of secondary causes of tremor, such as dystonia and parkinsonism
  2. Any contraindication to botulinum toxin injections (e.g. motor neuron disease, neuromuscular junction disease, etc.)
  3. History of surgical treatment for (ET).
  4. Dementia as defined by DSM-V criteria
  5. 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.
  6. 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.
  7. Significant renal, hepatic, cardiac and thyroid disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 150 units of abobotulinumtoxinA
150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU)
Drug: Botulinum toxin
Botulinum injections into dominant upper extremity using protocol outlined above.
Other Names:
  • BoNT
Other: Placebo
Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above
Experimental: 75 units of abobotulinumtoxinA
75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU
Drug: Botulinum toxin
Botulinum injections into dominant upper extremity using protocol outlined above.
Other Names:
  • BoNT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups.
Time Frame: 6 weeks

6 weeks post injection Clinician Global Impression if improvement Scale (CGIS)

Assessment of improvement graded by the patient on a -4 to +4 scale

  • -4 = severe worsening
  • 0 = no change
  • +4 = complete abolishment of symptoms

Higher scores represent better outcome.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups.
Time Frame: Baseline and 6 weeks
TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none/normal and 4 = very severe/high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal.
Baseline and 6 weeks
Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups.
Time Frame: 6 weeks

6 weeks post injection Clinician Global Impression if improvement Scale (CGIS)

Assessment of improvement graded by clinician on a -4 to +4 scale

  • -4 = severe worsening
  • 0 = no change
  • +4 = complete abolishment of symptoms

Higher scores represent better outcome.
6 weeks
Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group.
Time Frame: Baseline and 6 weeks
QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index.Positive index change values indicate that the score increased and negative values indicate that the score decreased.
Baseline and 6 weeks
Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks.
Time Frame: 6 weeks
the median of the differences in grip strength between baseline and week 6, A negative value indicates a decrease in grip strength in Kg at week 6.
6 weeks
12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group.
Time Frame: 12 weeks
TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none or normal and 4 = very severe or high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal.
12 weeks
12 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS)
Time Frame: 12 weeks

12 week post injection in Clinician Global Impression Scale-Improvement Subscale (CGIS)

Assessment of improvement graded by the clinician on a -4 to +4 scale

  • -4 = severe worsening
  • 0 = no change
  • +4 = complete abolishment of symptoms

Higher scores represent better outcome.
12 weeks
12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS)
Time Frame: 12 weeks

Patient Global Impression Scale-Improvement Subscale (PGIS)

Assessment of improvement graded by patient on a -4 to +4 scale

  • -4 = severe worsening
  • 0 = no change
  • +4 = complete abolishment of symptoms

Higher scores represent better outcome.
12 weeks
Difference of Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 12 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group.
Time Frame: Baseline and 12 weeks.
QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index. Positive index change values indicate that the score increased and negative values indicate that the score decreased.
Baseline and 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Hubert Fernandez, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-1519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Essential Tremor

Clinical Trials on Botulinum toxin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe