Trial Outcomes & Findings for Cognitive Dysfunction In Parkinson's (NCT NCT02468804)

Last Updated: 2021-07-27

Results Overview

The primary cognitive outcome will be the error rates on the N-back task measured before and after real or sham TMS as a measure of working memory. A negative number indicates that error rate was higher (working memory skills were worse) in the sham than the real condition. A positive number indicates lower error rates (better working memory skills) in the sham vs real stimulation.

Recruitment status

COMPLETED

Study phase

Target enrollment

107 participants

Primary outcome timeframe

Change immediately after a single session TMS (pre will be done 1 week prior)

Results posted on

2021-07-27

Participant Flow

PI withdrawal of subjects during MEG screening: Several participants have ferromagnetic compounds on their body, that they cannot remove (dental work, pins or screws in bones...) but cause artifacts in the data, which prevents proper data analysis. Participants are quickly screened for artifacts during their baseline visit and possibly withdrawn.

Participant milestones

Participant milestones
Measure	Parkinson's Disease Subjects Participants performed a working memory task during MEG recording. Then PD subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects.	Control Subjects Participants performed a working memory task during MEG recording. Then control subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded. REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects.
Overall Study STARTED	37	58
Overall Study COMPLETED	36	50
Overall Study NOT COMPLETED	1	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Dysfunction In Parkinson's

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parkinson's Disease Subjects n=36 Participants Participants performed a working memory task during MEG recording. Then PD subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects.	Control Subjects n=50 Participants Participants performed a working memory task during MEG recording. Then control subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects.	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	45 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 8.6 • n=5 Participants	37 years STANDARD_DEVIATION 18.1 • n=7 Participants	47 years STANDARD_DEVIATION 19.2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	23 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	50 participants n=7 Participants	86 participants n=5 Participants

PRIMARY outcome

Timeframe: Change immediately after a single session TMS (pre will be done 1 week prior)

Outcome measures

Outcome measures
Measure	Parkinson's Disease Subjects n=32 Participants Participants performed a working memory task during MEG recording. Then PD subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects.	Control Subjects n=20 Participants Participants performed a working memory task during MEG recording. Then control subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects.
Differences in Error Rates on the NBack Task Between Real and Sham Stimulation Trials	-0.79 incorrect responses Standard Deviation 0.94	-0.1 incorrect responses Standard Deviation 1.31

Adverse Events

Parkinson's Disease Subjects

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Parkinson's Disease Subjects n=36 participants at risk Participants performed a working memory task during MEG recording. Then PD subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects.	Control Subjects n=50 participants at risk Participants performed a working memory task during MEG recording. Then control subjects were randomized to receive a course of either real (rTMS) or sham TMS on a separate day (max 1 week after first MEG). 20 min after TMS subjects again performed the same working memory task while having MEG data recorded. REAL: Repetitive TMS was delivered at 20 Hz at 90% of the subjects resting motor threshold (RMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. SHAM: stimulation was delivered with the same TMS parameters as active simulation but the coil held at 90 degree to the scalp to induce similar somatic sensations and noise as in the active group with minimal brain effects.
Nervous system disorders headache	2.8% 1/36 • Number of events 1	0.00% 0/50

Additional Information

Isabelle Buard, PhD

University of Colorado Denver

Phone: (303)472-5973

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place