Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Apathy in Parkinson's Disease (NCT NCT00955032)

Results Overview

The apathy evaluation scale is a 14-item self-report questionaire that provides a quantitative estimate of apathy symptoms. Items are given a score of 0-3, and a total score is summated using all items. Scores may range between 0 and 42. Higher scores are indicative of greater symptoms of apathy, and a score of 14 is suggestive of clinically significant symptoms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Pre-Tx; 10 days post tx

Results posted on

2013-04-26

Participant Flow

Patients seen clinically for routine clinical care were determined by clinicians if they appeared to qualify for the study. Subjects were asked and consented in a non-coercive manner if they wished to be contacted via telephone about future study participation. Recruitment occurred between March 2007-December 2009.

Participant milestones

Participant milestones
Measure	rTMS Treatment Participants in this group received rTMS treatment.	Sham Treatment Participants in this group did not receive rTMS treatment.
Overall Study STARTED	16	8
Overall Study COMPLETED	16	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Apathy in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rTMS Treatment n=16 Participants Participants in this group received rTMS treatment.	Sham Treatment n=8 Participants Participants in this group did not receive rTMS treatment.	Total n=24 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	10 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age Continuous	63.8 years STANDARD_DEVIATION 7.2 • n=5 Participants	72.8 years STANDARD_DEVIATION 5.7 • n=7 Participants	66.8 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	8 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-Tx; 10 days post tx

Population: All participants who completed study procedures were included for analyses.

The apathy evaluation scale is a 14-item self-report questionaire that provides a quantitative estimate of apathy symptoms. Items are given a score of 0-3, and a total score is summated using all items. Scores may range between 0 and 42. Higher scores are indicative of greater symptoms of apathy, and a score of 14 is suggestive of clinically significant symptoms.

Outcome measures

Outcome measures
Measure	rTMS Pre TX n=16 Participants Participants in this group were assessed prior to rTMS treatment.	Sham Pre TX n=8 Participants Participants in this group were assessed before sham treatment.	rTMS Post TX (Immediate) n=16 Participants Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.	Sham Post Tx (Immediate) n=8 Participants Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
Apathy Evaluation Scale (AES)	19.6 units on a scale Standard Deviation 5.1	18.8 units on a scale Standard Deviation 3.9	17.9 units on a scale Standard Deviation 7.0	16.8 units on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Pre-Tx; 10 days post-tx

Population: All participants who completed study procedures were included for analyses.

The Lille Apathy Rating Scale (LARS) is a 33-item interviewer administered structured questionaire designed to assess level of apathetic symptoms. The first 3 items are scored from -2 to +2, while the remainder items are scored from -1 to +1. Scores can range between -36 to +36. The more positive the score, the greater level of apathy symptoms.

Outcome measures

Outcome measures
Measure	rTMS Pre TX n=16 Participants Participants in this group were assessed prior to rTMS treatment.	Sham Pre TX n=8 Participants Participants in this group were assessed before sham treatment.	rTMS Post TX (Immediate) n=16 Participants Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.	Sham Post Tx (Immediate) n=8 Participants Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
Lille Apathy Rating Scale (LARS)	-15.6 units on a scale Standard Deviation 9.1	-18.9 units on a scale Standard Deviation 4.5	-20.1 units on a scale Standard Deviation 7.8	-22.1 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: Pre-Tx; 10 days post-tx

Population: All participants who completed study procedures were included for analyses.

The Beck Depression Inventory-Second Edition (BDI-II) is a 21-item self-report questionaire that measures depressive symptoms. Each item is scored on a scale of 0-3, and items are summated to yield a total score. A higher score is indicative of greater symptoms of depression. Total scores may range between 0 and 63. A score greater than or equal of 14 is suggestive of clinically significant symptoms.

Outcome measures

Outcome measures
Measure	rTMS Pre TX n=16 Participants Participants in this group were assessed prior to rTMS treatment.	Sham Pre TX n=8 Participants Participants in this group were assessed before sham treatment.	rTMS Post TX (Immediate) n=16 Participants Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.	Sham Post Tx (Immediate) n=8 Participants Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
Beck Depression Inventory-Second Edition (BDI-II)	17.1 units on a scale Standard Deviation 8.4	17.8 units on a scale Standard Deviation 9.8	11.8 units on a scale Standard Deviation 8.8	11.8 units on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: Pre-Tx; 10 days post-tx

Population: All participants who completed study procedures were included for analyses.

The Hamilton Depression Rating Scale (HAM-D) is a 24-item interviewer administered structure questionaire designed to assess symptoms of depression. Items are scored with a range of 0-4, though 11 of the items are scored between 0 and 2. A total score is then calculated of all items which can range from 0 to 74. A higher score is indicative of more depressive symptoms, and a lower score post-tx is indicative of better outcome.

Outcome measures

Outcome measures
Measure	rTMS Pre TX n=16 Participants Participants in this group were assessed prior to rTMS treatment.	Sham Pre TX n=8 Participants Participants in this group were assessed before sham treatment.	rTMS Post TX (Immediate) n=16 Participants Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.	Sham Post Tx (Immediate) n=8 Participants Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
Hamilton Depression Rating Scale (HAM-D)	12.5 units on a scale Standard Deviation 7.3	11.9 units on a scale Standard Deviation 6.5	7.9 units on a scale Standard Deviation 4.8	8.5 units on a scale Standard Deviation 5.4

Adverse Events

rTMS Treatment

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Sham Treatment

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	rTMS Treatment n=16 participants at risk Participants in this group received rTMS treatment.	Sham Treatment n=8 participants at risk Participants in this group did not receive rTMS treatment.
General disorders Falling	0.00% 0/16 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.	12.5% 1/8 • Number of events 1 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.

Other adverse events

Other adverse events
Measure	rTMS Treatment n=16 participants at risk Participants in this group received rTMS treatment.	Sham Treatment n=8 participants at risk Participants in this group did not receive rTMS treatment.
General disorders Headache	12.5% 2/16 • Number of events 2 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.	0.00% 0/8 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.
General disorders Fatigue	6.2% 1/16 • Number of events 1 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.	12.5% 1/8 • Number of events 1 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.
General disorders Hallucination	0.00% 0/16 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.	12.5% 1/8 • Number of events 1 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.
General disorders Back Pain	6.2% 1/16 • Number of events 1 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.	12.5% 1/8 • Number of events 1 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.
General disorders Worsening PD symptoms	18.8% 3/16 • Number of events 3 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.	0.00% 0/8 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.
General disorders Fall	12.5% 2/16 • Number of events 2 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.	0.00% 0/8 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.
General disorders Pitting Edema	12.5% 2/16 • Number of events 2 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.	0.00% 0/8 • Adverse event data were collect from study enrollment to study completion, which occured between March 2007 - December 2009.

Additional Information

Dr. Hubert Fernandez

Center for Neurological Restoration Cleveland Clinic

Phone: (216) 445-1108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place