A Pilot Study of Shockwave Therapy in HSP

NCT ID: NCT05411627

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-15

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 Spastic Paraplegia (HSP). 8 participants will be treated with shockwave therapy targeting sites of maximal spasticity in the lower extremities for 3 sessions at a rate of once per week. Participants will fill out baseline questionnaires assessing their overall wellbeing and function prior to treatment session 1, and will complete follow-up questionnaires at visit 2, visit 3, a phone call within 7 days of visit 3, and 8 weeks after initial visit. Total time enrolled in the study will be 8 weeks

Conditions

Hereditary Spastic Paraplegia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Pilot group of all 8 anticipated participants

Group Type: EXPERIMENTAL

Shockwave Therapy

Intervention Type: DEVICE

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

Interventions

Shockwave Therapy

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Adam Tenforde

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2022P000682

Identifier Type: -

Identifier Source: org_study_id