- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05411627
A Pilot Study of Shockwave Therapy in HSP
February 6, 2024 updated by: Adam Tenforde, Spaulding Rehabilitation Hospital
A Pilot Study of Shockwave Therapy for Lower Extremity Spasticity in Persons With Genetically-Confirmed HSP
This is a pilot study of the efficacy, safety, and tolerability of shockwave therapy for the treatment of spasticity in Hereditary Spastic Paraplegia.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adam Tenforde, MD
- Phone Number: 617-952-6808
- Email: atenforde@partners.org
Study Contact Backup
- Name: Jonathan Fee, BS
- Phone Number: 781-850-5880
- Email: jfee1@bwh.harvard.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Pilot group of all 8 anticipated participants
|
Participants will receive shockwave therapy once per week for three weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale for Pain
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks
|
A rating of pain from 0 (none) to 10 (worst)
|
0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks
|
Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
The score of the rating scale ranges from 0-68, where 68 is a person who is completely asymptomatic.
|
0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
The score of this questionnaire ranges from 8 (least fatigue) to 40 (most fatigue)
|
0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
Foot and Ankle Ability Measure (FAAM) Questionnaire: Activities of Daily Living Subscale
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
The score of this questionnaire ranges from 0 (maximally symptomatic in activities of daily living) to 84 (asymptomatic in activities of daily living).
|
0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
Global Rate of Change (GROC) Questionnaire
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
The score ranges from -7 (maximally negative change) to +7 (maximally positive change)
|
0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
Neurological Quality of Life (Neuro-QoL) Questionnaire: Lower Extremity Function - Mobility Short Form
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
The score of this questionnaire ranges from 8 (minimal lower extremity function) to 40 (maximal lower extremity function)
|
0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
Neurological Quality of Life (Neuro-QoL) Questionnaire: Positive Affect and Wellbeing Short Form
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
The score of this questionnaire ranges from 9 (minimal wellbeing) to 45 (maximal wellbeing)
|
0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
Neurological Quality of Life (Neuro-QoL) Questionnaire: Satisfaction with Social Roles and Activities Short Form
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
The score of this questionnaire ranges from 8 (minimal satisfaction) to 40 (maximal satisfaction)
|
0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
Foot and Ankle Ability Measure (FAAM) Questionnaire: Sports Subscale
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
The score of this questionnaire ranges from 0 (maximally symptomatic in sports activities) to 32 (asymptomatic in sports activities)
|
0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
|
Ten-Meter Walk Test
Time Frame: 0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks
|
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.
|
0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2023
Primary Completion (Estimated)
October 15, 2023
Study Completion (Estimated)
December 15, 2023
Study Registration Dates
First Submitted
May 27, 2022
First Submitted That Met QC Criteria
June 6, 2022
First Posted (Actual)
June 9, 2022
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Peripheral Nervous System Diseases
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Paralysis
- Polyneuropathies
- Hereditary Sensory and Motor Neuropathy
- Paraplegia
- Spastic Paraplegia, Hereditary
Other Study ID Numbers
- 2022P000682
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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