Hereditary Spastic Paraplegia Clinical Trial
Official title:
A Pilot Study of Shockwave Therapy for Lower Extremity Spasticity in Persons With Genetically-Confirmed HSP
Verified date | February 2024 |
Source | Spaulding Rehabilitation Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a pilot study of the efficacy, safety, and tolerability of shockwave therapy for the treatment of spasticity in Hereditary Spastic Paraplegia.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 15, 2023 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Over the age of 18 2. Diagnosis of genetically-confirmed HSP 3. Score of 2, 3 or 4 on the PLSFRS walking question 4. 30 days stable dosages of oral spasticity medications prior to screening and throughout study participation 5. Able to come to site for treatment sessions 6. Able to understand all study procedures Exclusion Criteria: 1. Diagnosis of any other neurological disorder that may impact gait 2. Lower motor neuron (LMN) disease or combined UMN and LMN 3. Non-ambulatory or requiring two-person assistance for any functional ambulation on most days 4. Less than 3 months of symptoms 5. Have received SWT within the past 3 months 6. Prior botulinum toxin injection within 3 months or planning to receive botulinum toxin injections during the study participation for spasticity management 7. Presence of an intra-thecal baclofen pump 8. 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. 9. Patients with neuropathy affecting sensation to pain 10. Patients with a known underlying cardiac disease that could be affected by shockwave therapy 11. Concomitant intake of another clinical trial or other off-label experimental treatments that might influence study outcomes 12. Presence of unstable psychiatric disease, cognitive impairments, or dementia impairing study participation 13. Presence of other chronic neurological diseases such as Alzheimer's Parkinson's, stroke, or multiple sclerosis 14. Personal history of narcotic overuse for chronic pain or substance abuse or dependence 15. Contraindications for ESWT, including local skin breakdown, infection, malignancy or other soft tissue pathology at sites of planned treatment. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Spaulding Rehabilitation Hospital | Massachusetts General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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