Exercise to Augment TMS in Those With Treatment Resistant Depression

NCT05913401 | Active Not Recruiting

• 2 other identifiers: 2304-001P20GM130452
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Given the growing evidence that aerobic increases cortical excitability and promotes neuroplasticity, the scientific premise for its potential priming effect on the brain is strong. Combining AE with rTMS may produce a neural environment optimized for a robust physiological effect of rTMS, thereby leading to improved depression outcomes. With positive findings, this study would provide preliminary support for an innovative, safe and feasible approach for improving outcomes for this significant public health problem.

Conditions

Treatment Resistant Depression

Keywords

Aerobic Exercise; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

• Intervention Acceptability

  Percentage of participants approached for the study who agree to participate

  Baseline

• Feasibility of Intervention

  Percentage of sessions attended (out of a possible 30 sessions)

  6-weeks

Secondary Outcomes (3)

• Resting state motor thresholds

  6-weeks

• short-interval intracortical inhibition (SICI)

  6-weeks

• short-interval intracortical facilitation (SICF)

  6-weeks

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

Exercise sessions will be 20 minutes of moderate-intensity aerobic exercise on a treadmill. A treadmill is located on D1A within the space shared by the Butler Hospital TMS Clinic and the COBRE-support Neuromodulation Research Facility. A research staff member will monitor their heart rate and blood pressure to ensure safety and that activity is occurring at a moderate intensity (i.e., 64-76% of age predicted maximal heart rate). Participants will be asked to rate their affect and rating of perceived exertion (RPE) during exercise sessions. Sessions will include a 5-min warm-up and a 5-min cool-down to ensure safe exercise procedures. Participants will be asked to answer questions about affect before, during, and after exercise. These sessions will be supervised (i.e., they provide onsite coverage) by an exercise physiologist or medical staff member (e.g., nurse or physician) to ensure safety.

Behavioral: Aerobic Exercise

Video Condition

OTHER

In this condition, participants will be asked to sit and watch various documentaries or educational videos on topics NOT related to physical activity. These will last approximately 20 minutes and will occur before each TMS session.

Behavioral: Video Watching

Interventions

Aerobic Exercise BEHAVIORAL

20 minutes of supervised aerobic exercise on a treadmill prior to each TMS session

Aerobic Exercise

Video Watching BEHAVIORAL

20 minutes of watching documentaries or educational videos prior to each TMS session

Video Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult outpatients (age 18 and above) who are already approved to receive standard TMS therapy through the Butler Hospital TMS clinic.
• able to safely engage in moderate-intensity aerobic exercise (determined by a study physician)

You may not qualify if:

• Currently pregnant or plans to become pregnant in the next 6 weeks

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Exercise

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: February 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)