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A Pilot Study of Shockwave Therapy in HSP

Primary Purpose

Hereditary Spastic Paraplegia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shockwave Therapy
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hereditary Spastic Paraplegia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Over the age of 18
  2. Diagnosis of genetically-confirmed HSP
  3. Score of 2, 3 or 4 on the PLSFRS walking question
  4. 30 days stable dosages of oral spasticity medications prior to screening and throughout study participation
  5. Able to come to site for treatment sessions
  6. Able to understand all study procedures

Exclusion Criteria:

  1. Diagnosis of any other neurological disorder that may impact gait
  2. Lower motor neuron (LMN) disease or combined UMN and LMN
  3. Non-ambulatory or requiring two-person assistance for any functional ambulation on most days
  4. Less than 3 months of symptoms
  5. Have received SWT within the past 3 months
  6. Prior botulinum toxin injection within 3 months or planning to receive botulinum toxin injections during the study participation for spasticity management
  7. Presence of an intra-thecal baclofen pump
  8. Women who are pregnant. This is due to the fact that pregnancy will reduce participants activity after the treatment and the safety concerns related to shockwave treatment.
  9. Patients with neuropathy affecting sensation to pain
  10. Patients with a known underlying cardiac disease that could be affected by shockwave therapy
  11. Concomitant intake of another clinical trial or other off-label experimental treatments that might influence study outcomes
  12. Presence of unstable psychiatric disease, cognitive impairments, or dementia impairing study participation
  13. Presence of other chronic neurological diseases such as Alzheimer's Parkinson's, stroke, or multiple sclerosis
  14. Personal history of narcotic overuse for chronic pain or substance abuse or dependence
  15. Contraindications for ESWT, including local skin breakdown, infection, malignancy or other soft tissue pathology at sites of planned treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment Group

    Arm Description

    Pilot group of all 8 anticipated participants

    Outcomes

    Primary Outcome Measures

    Numerical Rating Scale for Pain
    A rating of pain from 0 (none) to 10 (worst)
    Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)
    The score of the rating scale ranges from 0-68, where 68 is a person who is completely asymptomatic.
    Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form
    The score of this questionnaire ranges from 8 (least fatigue) to 40 (most fatigue)
    Foot and Ankle Ability Measure (FAAM) Questionnaire: Activities of Daily Living Subscale
    The score of this questionnaire ranges from 0 (maximally symptomatic in activities of daily living) to 84 (asymptomatic in activities of daily living).
    Global Rate of Change (GROC) Questionnaire
    The score ranges from -7 (maximally negative change) to +7 (maximally positive change)
    Neurological Quality of Life (Neuro-QoL) Questionnaire: Lower Extremity Function - Mobility Short Form
    The score of this questionnaire ranges from 8 (minimal lower extremity function) to 40 (maximal lower extremity function)
    Neurological Quality of Life (Neuro-QoL) Questionnaire: Positive Affect and Wellbeing Short Form
    The score of this questionnaire ranges from 9 (minimal wellbeing) to 45 (maximal wellbeing)
    Neurological Quality of Life (Neuro-QoL) Questionnaire: Satisfaction with Social Roles and Activities Short Form
    The score of this questionnaire ranges from 8 (minimal satisfaction) to 40 (maximal satisfaction)
    Foot and Ankle Ability Measure (FAAM) Questionnaire: Sports Subscale
    The score of this questionnaire ranges from 0 (maximally symptomatic in sports activities) to 32 (asymptomatic in sports activities)
    Ten-Meter Walk Test
    Participants will be asked to walk ten meters 2x at their self-selected walking speed and 2x at their fast walking speed. Time taken to complete walks will be measured.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2022
    Last Updated
    November 7, 2022
    Sponsor
    Spaulding Rehabilitation Hospital
    Collaborators
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05411627
    Brief Title
    A Pilot Study of Shockwave Therapy in HSP
    Official Title
    A Pilot Study of Shockwave Therapy for Lower Extremity Spasticity in Persons With Genetically-Confirmed HSP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    October 15, 2023 (Anticipated)
    Study Completion Date
    December 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Spaulding Rehabilitation Hospital
    Collaborators
    Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a pilot study of the efficacy, safety, and tolerability of shockwave therapy for the treatment of spasticity in Hereditary Spastic Paraplegia.
    Detailed Description
    This is a pilot study investigating the efficacy, safety, and tolerability of Extracorporeal Shockwave Therapy (ESWT) for the treatment of lower-extremity spasticity in the setting of Hereditary Spastic Paraplegia (HSP). 8 participants will be treated with shockwave therapy targeting sites of maximal spasticity in the lower extremities for 3 sessions at a rate of once per week. Participants will fill out baseline questionnaires assessing their overall wellbeing and function prior to treatment session 1, and will complete follow-up questionnaires at visit 2, visit 3, a phone call within 7 days of visit 3, and 8 weeks after initial visit. Total time enrolled in the study will be 8 weeks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hereditary Spastic Paraplegia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    Pilot group of all 8 anticipated participants
    Intervention Type
    Device
    Intervention Name(s)
    Shockwave Therapy
    Intervention Description
    Participants will receive shockwave therapy once per week for three weeks.
    Primary Outcome Measure Information:
    Title
    Numerical Rating Scale for Pain
    Description
    A rating of pain from 0 (none) to 10 (worst)
    Time Frame
    0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks
    Title
    Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)
    Description
    The score of the rating scale ranges from 0-68, where 68 is a person who is completely asymptomatic.
    Time Frame
    0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
    Title
    Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form
    Description
    The score of this questionnaire ranges from 8 (least fatigue) to 40 (most fatigue)
    Time Frame
    0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
    Title
    Foot and Ankle Ability Measure (FAAM) Questionnaire: Activities of Daily Living Subscale
    Description
    The score of this questionnaire ranges from 0 (maximally symptomatic in activities of daily living) to 84 (asymptomatic in activities of daily living).
    Time Frame
    0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
    Title
    Global Rate of Change (GROC) Questionnaire
    Description
    The score ranges from -7 (maximally negative change) to +7 (maximally positive change)
    Time Frame
    0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
    Title
    Neurological Quality of Life (Neuro-QoL) Questionnaire: Lower Extremity Function - Mobility Short Form
    Description
    The score of this questionnaire ranges from 8 (minimal lower extremity function) to 40 (maximal lower extremity function)
    Time Frame
    0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
    Title
    Neurological Quality of Life (Neuro-QoL) Questionnaire: Positive Affect and Wellbeing Short Form
    Description
    The score of this questionnaire ranges from 9 (minimal wellbeing) to 45 (maximal wellbeing)
    Time Frame
    0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
    Title
    Neurological Quality of Life (Neuro-QoL) Questionnaire: Satisfaction with Social Roles and Activities Short Form
    Description
    The score of this questionnaire ranges from 8 (minimal satisfaction) to 40 (maximal satisfaction)
    Time Frame
    0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
    Title
    Foot and Ankle Ability Measure (FAAM) Questionnaire: Sports Subscale
    Description
    The score of this questionnaire ranges from 0 (maximally symptomatic in sports activities) to 32 (asymptomatic in sports activities)
    Time Frame
    0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
    Title
    Ten-Meter Walk Test
    Description
    Participants will be asked to walk ten meters 2x at their self-selected walking speed and 2x at their fast walking speed. Time taken to complete walks will be measured.
    Time Frame
    0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Over the age of 18 Diagnosis of genetically-confirmed HSP Score of 2, 3 or 4 on the PLSFRS walking question 30 days stable dosages of oral spasticity medications prior to screening and throughout study participation Able to come to site for treatment sessions Able to understand all study procedures Exclusion Criteria: Diagnosis of any other neurological disorder that may impact gait Lower motor neuron (LMN) disease or combined UMN and LMN Non-ambulatory or requiring two-person assistance for any functional ambulation on most days Less than 3 months of symptoms Have received SWT within the past 3 months Prior botulinum toxin injection within 3 months or planning to receive botulinum toxin injections during the study participation for spasticity management Presence of an intra-thecal baclofen pump Women who are pregnant. This is due to the fact that pregnancy will reduce participants activity after the treatment and the safety concerns related to shockwave treatment. Patients with neuropathy affecting sensation to pain Patients with a known underlying cardiac disease that could be affected by shockwave therapy Concomitant intake of another clinical trial or other off-label experimental treatments that might influence study outcomes Presence of unstable psychiatric disease, cognitive impairments, or dementia impairing study participation Presence of other chronic neurological diseases such as Alzheimer's Parkinson's, stroke, or multiple sclerosis Personal history of narcotic overuse for chronic pain or substance abuse or dependence Contraindications for ESWT, including local skin breakdown, infection, malignancy or other soft tissue pathology at sites of planned treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adam Tenforde, MD
    Phone
    617-952-6808
    Email
    atenforde@partners.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan Fee, BS
    Phone
    781-850-5880
    Email
    jfee1@bwh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Pilot Study of Shockwave Therapy in HSP

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