Multimodality Intervention for Function and Metabolism in SCI

NCT03576001 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2018P001431R01HD093724-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in VO2 Peak (L/Min) Achieved During Arm Ergometry Exercise Alone

  Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone

  Week 16

• Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Arm Ergometry Exercise Alone

  Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone

  Week 16

Secondary Outcomes (29)

• Change From Baseline in VO2 Peak (L/Min) Achieved During FES-LC Exercise Alone

  Week 16

• Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During FES-LC Exercise Alone

  Week 16

• Change From Baseline in VO2 Peak (L/Min) Achieved During Combined FES-LC and AE Exercise

  Week 16

• Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Combined FES-LC and AE Exercise

  Week 16

• Change From Baseline in Work Rate Max During Arm Ergometry Alone

  Week 16

Study Arms (2)

Multi-modality intervention group

EXPERIMENTAL

Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate

Drug: Testosterone Undecanoate; Behavioral: hybrid exercise

Placebo group

PLACEBO COMPARATOR

Hybrid exercise plus placebo medication

Behavioral: hybrid exercise

Interventions

Testosterone Undecanoate DRUG

administered through injections by study staff

Multi-modality intervention group

hybrid exercise BEHAVIORAL

hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based

Multi-modality intervention group; Placebo group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, 19 to 70 years
• Confirmed cervical and thoracic, AIS A-D who are at least 6 months post-injury and who use a wheelchair as their primary mobility mode
• Medically stable, able to follow directions
• Able to provide informed consent.
• For females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to Day 1 and agreement to use such a method during study participation and for an additional 12 weeks after the end of intervention.

You may not qualify if:

• Upper extremity musculoskeletal conditions (such as advanced rotator cuff pathology or carpal tunnel syndrome) or neurological disorder that in the assessment of the study investigator would prevent the participant from performing the prescribed arm ergometry.
• Current fractures in the upper and lower extremity
• In accordance with the Endocrine Society and ISSAM Guidelines25,52, we will exclude individuals with a contraindication for androgen use:
• History of prostate or breast cancer
• Prostate nodule or induration on digital rectal examination (DRE)
• Prostate specific antigen (PSA) \> 4 ng/ml or \> 3 ng/ml in individuals at high risk of prostate cancer such as African Americans or those with family history of prostate cancer in first degree relatives, unless there has been a negative prostate biopsy within 3 months
• Hematocrit \> 48%
• Conditions that would render exercise and FES unsafe or unfeasible such as severe autonomic dysreflexia, severe pressure sores, severe spasticity and severe pain.
• Body mass index (BMI) \> 45 kg/m2
• Renal dysfunction as indicated by GFR of \<50 ml/min, estimated by using the Modification of Diet in Kidney Disease (MDRD) Study equation, in accordance with K/DOQI guidelines
• Use of testosterone or other anabolic therapies, including DHEA and androstenedione, or rhGH in the preceding 6 months
• Active cancer requiring therapy and which may limit life expectancy to less than 5 years
• Psychosis, bipolar disorder, or major untreated depression
• Dementia (Mini-Mental Status Exam \[MMSE\] \<24)
• Myocardial infarction (MI) or stroke within 3 months of entry

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Spaulding Rehabilitation Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Valderrabano RJ, Pencina K, Shang YV, Echevarria E, Dixon R, Ghattas C, Wilson L, Reid KF, Storer T, Garrahan M, Tedtsen T, Zafonte R, Bouxsein M, Bhasin S. Bone microarchitectural alterations associated with spinal cord injury: Relation to sex hormones, metabolic factors, and loading. Bone. 2024 Apr;181:117039. doi: 10.1016/j.bone.2024.117039. Epub 2024 Feb 5.

  PMID: 38325649 DERIVED

• Reid KF, Storer TW, Pencina KM, Valderrabano R, Latham NK, Wilson L, Ghattas C, Dixon R, Nunes A, Bajdek N, Huang G, Skeels SE, Lin AP, Merugumala SM, Liao HJ, Bouxsein ML, Zafonte RD, Bhasin S. A multimodality intervention to improve musculoskeletal health, function, metabolism, and well-being in spinal cord injury: study protocol for the FIT-SCI randomized controlled trial. BMC Musculoskelet Disord. 2022 May 25;23(1):493. doi: 10.1186/s12891-022-05441-3.

  PMID: 35614404 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Shalender Bhasin
• Organization: Brigham and Women's Hosptial

sbhasin@bwh.harvard.edu

617-732-5661

Study Officials

• Shalender Bhasin, MB BS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 3, 2018
• Study Start: August 23, 2019
• Primary Completion: January 15, 2025
• Study Completion: March 30, 2025
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)