Status:
WITHDRAWN
A Pilot Study of Shockwave Therapy in HSP
Lead Sponsor:
Spaulding Rehabilitation Hospital
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Hereditary Spastic Paraplegia
Eligibility:
All Genders
18+ years
Phase:
NA
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 Spast...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05411627
Start Date
January 1 2023
End Date
December 15 2023
Last Update
February 8 2024
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