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Completed

NCT Number: NCT02909907

Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for 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).

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Botulinum toxin

Drug

Botulinum injections into dominant upper extremity using protocol outlined above.

Other names: BoNT

Placebo

Other

Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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)

Acronym: FLEX-D ET

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2016
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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