Effects of Botulinum Toxin on Muscle and Brain Activity

NCT02837185 | Terminated

• 1 other identifier: IRB201600759
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look into the effects of Botulinum Toxin in patients with primary cervical dystonia. The effects will be determined by neck muscle activity measurements and brain function activity measurements. The goal of the study is to try to identify markers of the effects of Botulinum toxin.

Conditions

Cervical Dystonia, Primary

Keywords

Cervical dystonia; Transcranial magnetic stimulation; Electromyography; TMS; EMG

Outcome Measures

Primary Outcomes (2)

• Changes in TMS measures

  Baseline, BoNT ON (around 6 weeks), BoNT OFF (around 12 weeks) for Arm 1; Arm 2 measured only at baseline

• Changes in EMG measures

  baseline, BoNT ON (around 6 weeks), BoNT OFF (around 12 weeks) for Arm 1; Arm 2 measured only at baseline

Secondary Outcomes (1)

• Changes in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

  0, BoNT ON (around 6 weeks), BoNT OFF (around 12 weeks) for Arm 1 only

Study Arms (2)

Cervical Dystonia

EXPERIMENTAL

'Botulinum Toxin injection' will be done and 'physiological measures' will then be collected.

Procedure: Botulinum Toxin injection; Other: Physiological measures

Healthy controls

OTHER

No Botulinum toxin is injected, 'physiological measures' will be collected as a healthy comparator.

Other: Physiological measures

Interventions

Botulinum Toxin injection PROCEDURE

Botulinum toxin injection for cervical dystonia subjects (as part of clinical care)

Cervical Dystonia

Physiological measures OTHER

These include TMS and EMG measurements

Cervical Dystonia; Healthy controls

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis: PCD
• Receiving BoNT at the University of Florida (UF)

You may not qualify if:

• Secondary torticollis
• Pregnancy
• Active seizure disorder
• Presence of metallic body such as pacemaker, implants, metal rods and hearing aid
• Age 21-80 years
• Any form of torticollis
• Pregnancy
• Active seizure disorder
• Presence of metallic body such as pacemaker, implants, metal rods and hearing aid

Sponsors & Collaborators

• University of Florida: lead
• Dystonia Medical Research Foundation: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Cervical Dystonia, Primary; Torticollis

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Aparna Wagle Shukla

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 19, 2016
• Study Start: August 1, 2016
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)