Trial Outcomes & Findings for TMS and Exercise for Post-stroke Pain (NCT NCT04672044)

NCT ID: NCT04672044

Last Updated: 2025-06-15

Results Overview

The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline and 30 days after last intervention.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

From baseline to follow-up 30 days after last intervention

Results posted on

2025-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Active rTMS+Exercise active rTMS Active rTMS and exercise: active	Sham rTMS+Exercise sham rTMS Sham rTMS+Exercise: sham
Overall Study STARTED	5	4
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TMS and Exercise for Post-stroke Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active rTMS+Exercise n=5 Participants active rTMS Active rTMS and exercise: active	Sham rTMS+Exercise n=4 Participants sham rTMS Sham rTMS+Exercise: sham	Total n=9 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 8.9 • n=5 Participants	59.9 years STANDARD_DEVIATION 7.6 • n=7 Participants	62 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to follow-up 30 days after last intervention

Population: Only participants completing both the baseline and followup mRS assessment were included in this analysis.

Outcome measures

Outcome measures
Measure	Active rTMS+Exercise n=4 Participants Patients with post-stroke headaches. Active arm: active rTMS and exercise	Sham rTMS+Exercise n=2 Participants Patients with post-stroke headaches. Control arm: Sham rTMS and exercise arm.
Change in Modified Rankin Scale From Baseline to Follow-up 30 Days After Last Intervention	0 units on a scale Standard Deviation 0	1 units on a scale Standard Deviation 1.41

Adverse Events

Active rTMS+Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham rTMS+Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Integrity Officer

Birmingham VA Medical Center

Phone: 2059338101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place