Back to resultsA 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
About this trial
This is an interventional treatment trial for Hereditary Spastic Paraplegia
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.
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
NCT ID
NCT05411627
First Posted
May 27, 2022
Last Updated
November 7, 2022
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Massachusetts General Hospital
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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