A Pilot Study of Shockwave Therapy in HSP

NCT05411627 | Withdrawn FDA Device

• 1 other identifier: 2022P000682
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hereditary Spastic Paraplegia

Outcome Measures

Primary Outcomes (10)

• Numerical Rating Scale for Pain

  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)

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (1)

Treatment Group

EXPERIMENTAL

Pilot group of all 8 anticipated participants

Device: Shockwave Therapy

Interventions

Shockwave Therapy DEVICE

Participants will receive shockwave therapy once per week for three weeks.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 18
• Diagnosis of genetically-confirmed HSP
• Score of 2, 3 or 4 on the PLSFRS walking question
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Massachusetts General Hospital: collaborator

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 9, 2022
• Study Start: January 1, 2023
• Primary Completion: October 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share