Neurotoxin and Physical Therapy

NCT02177617 | Completed Phase 4 Results FDA Device

• 1 other identifier: IRB201400343
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare Botox injections without Physical Therapy sessions to Botox injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms and quality of life more than Botox alone. It is also expected that Botox combined with Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox injection.

Conditions

Cervical Dystonia

Keywords

Cervical Dystonia; Botox

Outcome Measures

Primary Outcomes (3)

• Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

  The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is a measure of symptoms, pain, and disability related to Cervical Dystonia. The total TWSTRS scale includes a global outcome score (total score) and scores on each of 3 subscales for severity (0-35), disability (0-30), and pain (0-20), which are summed together for a total score (0-85), with higher scores indicating greater impairment. The TWSTRS is completed by a neurologist who visually assesses the patient's symptoms, and asks the patient to self-report on pain and disability.

  absolute value at Week 12

• SF-36 Physical Functioning Subscore

  The Short Form 36-Item Health Scale (SF-36) is a health survey with 36 questions that is self-reported by the study participant. It contains 8 subscales, one of which is Physical Functioning, calculated from 10 of the 36 questions. Different questions have different score ranges and valences. Therefore, their response for each question is linearly transformed to a value of 0-100 (for example, choosing response 3 on a scale of 1-5 is transformed to 60). These ten values are then averaged to generate the Physical Functioning subscore, ranging from 0-100. The higher the response value and the subscore, the higher degree of physical functioning. More details on RAND SF-36 scoring here: https://www.rand.org/health-care/surveys\_tools/mos/36-item-short-form/scoring.html

  absolute value at Week 12

• Clinical Global Impression Scale (CGIS)

  This scale is an investigator-rated scale that measures illness severity on a single 7-point scale (1-7). Higher scores represent greater severity of illness.

  absolute value at Week 12

Secondary Outcomes (1)

• Mean MEP After Paired Associative Stimulation (PASmean)

  absolute value at week 12

Other Outcomes (2)

• Visual Analog Scale

  absolute value at 12 weeks

• Cervical Range of Motion Measurement

  absolute value at 12 weeks was calculated

Study Arms (2)

Botox only

ACTIVE COMPARATOR

Participants randomized to receive Botox injections alone.

Drug: Botox injection; Procedure: Transcranial magnetic stimulation (TMS)

Botox plus Physical Therapy

ACTIVE COMPARATOR

Participants randomized to receive Botox injection combined with Physical Therapy

Drug: Botox injection; Behavioral: Physical Therapy; Procedure: Transcranial magnetic stimulation (TMS)

Interventions

Botox injection DRUG

Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms

Also known as: Neurotoxin

Botox only; Botox plus Physical Therapy

Physical Therapy BEHAVIORAL

Participants will undergo physical therapy sessions with a physical therapist trained in movement disorders. Participants will be instructed to continue these exercises five times per week, and will be called weekly by the investigator to check progress.

Botox plus Physical Therapy

Transcranial magnetic stimulation (TMS) PROCEDURE

For these tests, participants will sit in a chair that looks like one found at the dentist's office. A nerve stimulator will be placed on the wrist of the right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of the head.

Botox only; Botox plus Physical Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 with a diagnosis of Cervical Dystonia, which will be confirmed by a movement disorders specialist
• Positive response to at least two prior treatments with Botox as indicated by an improvement in Clinical Global Improvement Scale.
• Received last dose of Botox a minimum of 12 weeks prior to baseline visit.

You may not qualify if:

• Any conditions that would contraindicate transcranial magnetic stimulation (for example, pregnancy or epilepsy)
• Any secondary, fixed, post-traumatic, or psychogenic dystonia

Sponsors & Collaborators

• University of Florida: lead
• American Academy of Neurology: collaborator
• National Ataxia Foundation: collaborator
• American Brain Foundation: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type A; Neurotoxins; Physical Therapy Modalities; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Noxae; Toxic Actions; Chemical Actions and Uses; Therapeutics; Rehabilitation; Magnetic Field Therapy

Results Point of Contact

• Title: Aparna Wagle Shukla
• Organization: University of Florida

aparna.shukla@neurology.ufl.edu

3522945400

Study Officials

• Aparna Wagle Shukla, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Michael S Okun, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 27, 2014
• Study Start: December 1, 2014
• Primary Completion: January 7, 2017
• Study Completion: January 7, 2017
• Last Updated: August 2, 2023
• Results First Posted: August 2, 2023

Record last verified: 2023-08

Locations

US (1)