Trial Outcomes & Findings for Effects of Neuromodulation and Rehabilitation of the Locomotor Network in Freezing of Gait (NCT NCT03273270)

Last Updated: 2021-03-29

Results Overview

Change (pre vs post intervention) in resting-state fMRI connectivity (fisher z-score) of the supplemental motor area (SMA). A negative change score means there was a reduction in SMA connectivity pre to post intervention. A positive change score means there was an increase in SMA connectivity pre to post intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

pre and post intervention (within one week of completion)

Results posted on

2021-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Active TMS + Gait Training 1 Hz repetitive transcranial magnetic stimulation transcranial magnetic stimulation: transcranial magnetic stimulation	Sham TMS + Gait Training No active stimulation transcranial magnetic stimulation: transcranial magnetic stimulation
Overall Study STARTED	12	8
Overall Study COMPLETED	12	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Neuromodulation and Rehabilitation of the Locomotor Network in Freezing of Gait

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active TMS + Gait Training n=12 Participants 1 Hz repetitive transcranial magnetic stimulation transcranial magnetic stimulation: transcranial magnetic stimulation	Sham TMS + Gait Training n=8 Participants No active stimulation transcranial magnetic stimulation: transcranial magnetic stimulation	Total n=20 Participants Total of all reporting groups
Age, Continuous	66.6 years STANDARD_DEVIATION 7.5 • n=5 Participants	64.5 years STANDARD_DEVIATION 8.9 • n=7 Participants	65.8 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: pre and post intervention (within one week of completion)

Population: participant did not receive post scan due to discomfort in scanner

Outcome measures

Outcome measures
Measure	Active TMS + Gait Training n=11 Participants 1 Hz repetitive transcranial magnetic stimulation transcranial magnetic stimulation: transcranial magnetic stimulation	Sham TMS + Gait Training n=8 Participants No active stimulation transcranial magnetic stimulation: transcranial magnetic stimulation
Change in Functional Connectivity to the Supplementary Motor Area.	-.176 z-score Standard Deviation .102	.190 z-score Standard Deviation 0.119

SECONDARY outcome

Timeframe: pre and post intervention (within one week of completion)

The new freezing of gait questionnaire is a measure of freezing severity (total score range: 0-28) wherein higher scores represent worse freezing behavior. The outcome measures represent the change in freezing of gait questionnaire score from pre to post intervention. A larger, positive value represents a greater reduction in freezing severity and a better outcome.

Outcome measures

Outcome measures
Measure	Active TMS + Gait Training n=12 Participants 1 Hz repetitive transcranial magnetic stimulation transcranial magnetic stimulation: transcranial magnetic stimulation	Sham TMS + Gait Training n=8 Participants No active stimulation transcranial magnetic stimulation: transcranial magnetic stimulation
Change in New Freezing of Gait Questionnaire	4.83 score on a scale Standard Deviation 5.72	1.75 score on a scale Standard Deviation 3.24

SECONDARY outcome

Timeframe: pre and post intervention (within one week of completion)

Population: Missing a pre to post measurement for one participant in the sham group

The time to turn around a cone (in seconds) while dual tasking (performing a serial 7s and/or every other letter of the alphabet task) was measured while participants were in the OFF state (off of their Parkinson's medication). The assessment were performed pre to post intervention. A greater reduction in time to turn (pre versus post interverntion) is represented by a larger positive number. A larger reduction in time to turn represents a better outcome.

Outcome measures

Outcome measures
Measure	Active TMS + Gait Training n=12 Participants 1 Hz repetitive transcranial magnetic stimulation transcranial magnetic stimulation: transcranial magnetic stimulation	Sham TMS + Gait Training n=7 Participants No active stimulation transcranial magnetic stimulation: transcranial magnetic stimulation
Change in Dual Task Time to Turn Off	12.05 seconds Standard Deviation 40.52	5.88 seconds Standard Deviation 11.94

Adverse Events

Active TMS + Gait Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham TMS + Gait Training

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

Gonzalo Revuelta

Medical University of South Carolina

Phone: 7927262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place