A Pilot Study of Shockwave Therapy in HSP (NCT05411627) | Clinical Trial Compass
WithdrawnNot Applicable
A Pilot Study of Shockwave Therapy in HSP
Stopped: funding issues
0Started 2023-01-01
Plain-language summary
This is a pilot study of the efficacy, safety, and tolerability of shockwave therapy for the treatment of spasticity in Hereditary Spastic Paraplegia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numerical Rating Scale for Pain
Timeframe: 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks
. 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.
Neurological Quality of Life (Neuro-QoL) Questionnaire: Positive Affect and Wellbeing Short Form
Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
8
Neurological Quality of Life (Neuro-QoL) Questionnaire: Satisfaction with Social Roles and Activities Short Form
Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
9
Foot and Ankle Ability Measure (FAAM) Questionnaire: Sports Subscale
Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
10
Ten-Meter Walk Test
Timeframe: 0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks