NCT03086551

Modulating Interaction of Motor Learning Networks in Rehabilitation of Stroke

Completed NA Results posted Last updated 27 April 2020

What this trial tests

NA trial testing Active continuous theta burst stimulation (cTBS) in Stroke in 12 participants. Completed in 30 March 2019.

Timeline

1 April 2016

Primary endpoint
30 March 2019

30 March 2019

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	12
Start date	1 April 2016
Primary completion	30 March 2019
Estimated completion	30 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Active continuous theta burst stimulation (cTBS)
• Placebo (Sham) continuous theta burst stimulation
• Motor Practice

Conditions studied

• Stroke — all drugs for Stroke →
• Stroke, Chronic — all drugs for Stroke, Chronic →
• Stroke, Middle Cerebral Artery With Infarction — all drugs for Stroke, Middle Cerebral Artery With Infarction →

Sponsor

University of Michigan

Who can join

Adults 50 to 75, any sex, with Stroke or Stroke, Chronic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Sequential Response Time to Post-Intervention Primary · Baseline and post-intervention

Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to any practice and at a delayed retention test (e.g. no warm up or preceding practice) post-intervention. Change between the baseline average and post-intervention average was also calculated by subtracting post-intervention score from pre-intervention score. Positive numbers represent improvement in ability.

Time to Complete Sequence (Baseline)

Group	Value	95% CI
Active+Motor Practice	8.68	± 2.06
Sham+Motor Practice	8.84	± 1.47

Time to Complete Sequence (Delayed Retention)

Group	Value	95% CI
Active+Motor Practice	8.32	± 1.55
Sham+Motor Practice	7.96	± 1.04

Change in Time (Pre to Post)

Group	Value	95% CI
Active+Motor Practice	0.37	± 0.65
Sham+Motor Practice	0.88	± 0.63

Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test Secondary · Baseline and post-intervention

The Jebsen-Taylor Hand Function Test is comprised of a series of unimanual tasks required for activities of daily living. Time to complete the Jebsen-Taylor Hand Function Test was assessed at baseline and post-intervention by taking the aggregate time to complete each activity. Change in time to complete the Jebsen-Taylor Hand Function Test between the baseline and post-intervention tests was derived by subtracting post-intervention score from baseline score. Positive scores indicate improvement in functional motor ability.

Pre Time to Complete (Stroke Affected Limb)

Group	Value	95% CI
Active+Motor Practice	95.68	± 51.71
Sham+Motor Practice	86.07	± 17.78

Post Time to Complete (Stroke Affected Limb)

Group	Value	95% CI
Active+Motor Practice	100.05	± 60.47
Sham+Motor Practice	76.27	± 20.97

Change Pre to Post (Stroke Affected Limb)

Group	Value	95% CI
Active+Motor Practice	-4.38	± 8.95
Sham+Motor Practice	9.80	± 6.14

Pre Time to Complete (Non-Stroke Affected Limb)

Group	Value	95% CI
Active+Motor Practice	55.75	± 11.22
Sham+Motor Practice	66.67	± 20.87

Post Time to Complete (Non-Stroke Affected Limb)

Group	Value	95% CI
Active+Motor Practice	51.97	± 8.25
Sham+Motor Practice	64.95	± 24.07

Change Pre to Post (Non-Stroke Affected Limb)

Group	Value	95% CI
Active+Motor Practice	3.78	± 5.33
Sham+Motor Practice	1.72	± 5.40

Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) Secondary · Within session baseline to ~8 minutes post-application of non-invasive stimulation within the same session

Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to application of Active+Motor Practice or Sham+Motor Practice for each intervention session and the first ten sequences of practice immediately following the specific form of non-invasive brain stimulation within each session. Change within a session was calculated by subtracting the post-stimulation score from the pre-stimulation score within a session. Positive values represent improved ability.

Session 1

Group	Value	95% CI
Active+Motor Practice	0.41	± 0.70
Sham+Motor Practice	0.89	± 0.36

Session 2

Group	Value	95% CI
Active+Motor Practice	0.72	± 1.97
Sham+Motor Practice	0.80	± 1.86

Session 3

Group	Value	95% CI
Active+Motor Practice	-0.20	± 0.60
Sham+Motor Practice	0.22	± 0.62

Session 4

Group	Value	95% CI
Active+Motor Practice	0.35	± 0.46
Sham+Motor Practice	0.23	± 0.39

Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention Secondary · Baseline and post-intervention

Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts.

MEP Amplitude Pre (120% of RMT)

Group	Value	95% CI
Active+Motor Practice	1558	± 1020
Sham+Motor Practice	971	± 709

MEP Amplitude Post (120% of RMT)

Group	Value	95% CI
Active+Motor Practice	1216	± 1161
Sham+Motor Practice	511	± 279

MEP Amplitude Pre (150% of RMT)

Group	Value	95% CI
Active+Motor Practice	2750	± 2172
Sham+Motor Practice	1977	± 218

MEP Amplitude Post (150% of RMT)

Group	Value	95% CI
Active+Motor Practice	2008	± 2062
Sham+Motor Practice	2495	± 609

Change From Baseline in Cortical Excitability Post-Intervention Secondary · Baseline and post-intervention

Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts. Change in motor evoked potential amplitude elicited by transcranial magnetic stimulation intensities of 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshol

% change in MEP (120% RMT)

Group	Value	95% CI
Active+Motor Practice	-26	± 35
Sham+Motor Practice	-19	± 58

% change in MEP (150% RMT)

Group	Value	95% CI
Active+Motor Practice	-17	± 37
Sham+Motor Practice	25	± 17

Sponsor's own description

This study uses a form on non-invasive brain stimulation called transcranial magnetic stimulation to understand 1) understand how the brain learns post-stroke and 2) assess non-invasive brain stimulation as an addition to current stroke rehabilitation approaches. In two study arms the investigators will compare the effect of active transcranial magnetic stimulation paired with motor practice with placebo (or sham) transcranial magnetic stimulation paired with the same motor practice.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.