Hereditary Spastic ParaplegiaNCT05411627
A Pilot Study of Shockwave Therapy in HSP
A study testing Shockwave Therapy in people with Hereditary Spastic Paraplegia, run by Spaulding Rehabilitation Hospital.
Trial summary
This is a pilot study of the efficacy, safety, and tolerability of shockwave therapy for the treatment of spasticity in Hereditary Spastic Paraplegia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Spastic Paraplegia
- What is being tested?
- Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
Official title: 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.
Read the 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
- Conditions
- Hereditary Spastic Paraplegia
- Being tested
- Shockwave Therapy
- Medical subject headings
- Spastic Paraplegia, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave TherapyDevice
Participants will receive shockwave therapy once per week for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Pilot group of all 8 anticipated participants Receives: Device: Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale for Pain
A rating of pain from 0 (none) to 10 (worst)
Measured: 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks
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.
Measured: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form
The score of this questionnaire ranges from 8 (least fatigue) to 40 (most fatigue)
Measured: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
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).
Measured: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
Global Rate of Change (GROC) Questionnaire
The score ranges from -7 (maximally negative change) to +7 (maximally positive change)
Measured: 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
The score of this questionnaire ranges from 8 (minimal lower extremity function) to 40 (maximal lower extremity function)
Measured: 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
The score of this questionnaire ranges from 9 (minimal wellbeing) to 45 (maximal wellbeing)
Measured: 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
The score of this questionnaire ranges from 8 (minimal satisfaction) to 40 (maximal satisfaction)
Measured: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
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)
Measured: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
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.
Measured: 0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jan 2023 (estimated)
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Why it stopped: funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Spastic ParaplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Adam Tenforde, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411627
- Sponsor's protocol ID
- 2022P000682
- Status last verified
- Feb 2024
- First submitted
- 27 May 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Shockwave Therapy for Lower Extremity Spasticity in Persons With Genetically-Confirmed HSP
- ClinicalTrials.gov ID
- NCT05411627
- Acronym / sponsor ID
- 2022P000682
- Conditions
- Hereditary Spastic Paraplegia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Shockwave TherapyPilot group of all 8 anticipated participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave TherapyParticipants will receive shockwave therapy once per week for three weeks. | Device | Treatment Group |
Primary outcome
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)
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.
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)
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).
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)
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)
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)
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)
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)
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave Therapy in people with Hereditary Spastic Paraplegia, run by Spaulding Rehabilitation Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale for Pain (time frame: 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.