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 range18 Years

SexALL

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
✕. 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.

What they're measuring

Numerical Rating Scale for Pain

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks

Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks

Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks

Foot and Ankle Ability Measure (FAAM) Questionnaire: Activities of Daily Living Subscale

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks

Global Rate of Change (GROC) Questionnaire

Timeframe: 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

Timeframe: 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

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks

Trial details

NCT IDNCT05411627

SponsorSpaulding Rehabilitation Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-15

View on ClinicalTrials.gov More Hereditary Spastic Paraplegia trials

Who can participate

Age range18 Years

SexALL

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
✕. 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.

What they're measuring

Numerical Rating Scale for Pain

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks

Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks

Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks

Foot and Ankle Ability Measure (FAAM) Questionnaire: Activities of Daily Living Subscale

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks

Global Rate of Change (GROC) Questionnaire

Timeframe: 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

Timeframe: 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

Timeframe: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks