Trial Outcomes & Findings for Evaluation of Intensive Language Therapy (NCT NCT02935842)

NCT ID: NCT02935842

Last Updated: 2020-06-02

Results Overview

Gait Velocity: meters per second

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).

Results posted on

2020-06-02

Participant Flow

From May 2015 to February 2018, N=32 patients with idiopathic Parkinson's disease (PD) were recruited from the University Hospital Basel (Switzerland) and N=22 healthy controls (HC) were recruited from senior health centers or sports groups independent of the hospital.

Eligibility assessments were conducted by neurologists, neuropsychologists and speech-language therapists. Eligibility criteria led to 12 exclusions in the PD group and to 4 exclusions in the HC group. Therefore, final N count for the study were: N=20 PD patients and N=18 HC.

Participant milestones

Participant milestones
Measure
rSLT, Then no Therapy, Then rBMT
Specific, intensive and high-frequency speech-language-therapy (rSLT). Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total. Please note: this was a case-crossover study. Participants, who completed the above stated and described intervention, had then the opportunity to switch to the 'no therapy' group. After having completed the 6 months 'no therapy' period, the participant could enrol again into the 'rhythmic balance-movement training'' rBMT).
rBMT, Then 'no Therapy', Then rSLT
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total. Please note: this was a case-crossover study. Participants, who completed the above stated and described intervention, had then the opportunity to switch to the 'no therapy' group. After having completed the 6-months period as 'no therapy', the participant could switch to the 'rhythmic speech-language therapy' group (rSLT).
No Therapy, Then rSLT, Then rBMT
"the 6-months-waiting list". Patients with Parkinson's disease (PD) who had to wait for/ or chose to receive treatments at a later time. Please note: this was a case-crossover study. After completing the 6-month waiting list (no therapy), participants had then the opportunity to switch to another study arm (being 'rhythmic speech-language therapy' (rSLT) or 'rhythmic balance-movement training' (rBMT). After having completed the second intervention program, the participant could enrol again into a study arm, which he/she has not been before (i.e. either 'rhythmic speech-language therapy' (rSLT) or 'rhythmic balance-movement training'' rBMT).
Healthy Controls; no Therapy
Healthy Controls received no therapy.
Testing and Therapy Period 1
STARTED
8
6
6
0
Testing and Therapy Period 1
COMPLETED
8
6
6
0
Testing and Therapy Period 1
NOT COMPLETED
0
0
0
0
Testing and Therapy Period 2
STARTED
8
6
6
0
Testing and Therapy Period 2
COMPLETED
6
6
6
0
Testing and Therapy Period 2
NOT COMPLETED
2
0
0
0
Testing and Therapy Period 3
STARTED
6
6
6
18
Testing and Therapy Period 3
COMPLETED
3
2
1
17
Testing and Therapy Period 3
NOT COMPLETED
3
4
5
1

Reasons for withdrawal

Reasons for withdrawal
Measure
rSLT, Then no Therapy, Then rBMT
Specific, intensive and high-frequency speech-language-therapy (rSLT). Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total. Please note: this was a case-crossover study. Participants, who completed the above stated and described intervention, had then the opportunity to switch to the 'no therapy' group. After having completed the 6 months 'no therapy' period, the participant could enrol again into the 'rhythmic balance-movement training'' rBMT).
rBMT, Then 'no Therapy', Then rSLT
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total. Please note: this was a case-crossover study. Participants, who completed the above stated and described intervention, had then the opportunity to switch to the 'no therapy' group. After having completed the 6-months period as 'no therapy', the participant could switch to the 'rhythmic speech-language therapy' group (rSLT).
No Therapy, Then rSLT, Then rBMT
"the 6-months-waiting list". Patients with Parkinson's disease (PD) who had to wait for/ or chose to receive treatments at a later time. Please note: this was a case-crossover study. After completing the 6-month waiting list (no therapy), participants had then the opportunity to switch to another study arm (being 'rhythmic speech-language therapy' (rSLT) or 'rhythmic balance-movement training' (rBMT). After having completed the second intervention program, the participant could enrol again into a study arm, which he/she has not been before (i.e. either 'rhythmic speech-language therapy' (rSLT) or 'rhythmic balance-movement training'' rBMT).
Healthy Controls; no Therapy
Healthy Controls received no therapy.
Testing and Therapy Period 2
Withdrawal by Subject
2
0
0
0
Testing and Therapy Period 3
Required other therapy (dysphagia)
1
2
2
0
Testing and Therapy Period 3
Accident prior to treatment
2
2
0
0
Testing and Therapy Period 3
Lost to Follow-up
0
0
0
1
Testing and Therapy Period 3
Withdrawal by Subject
0
0
3
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
rSLT, Then no Therapy, Then rBMT
n=8 Participants
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total. Then participants could be allocated to the no-therapy group, and after 6-month completion again into the rBMT intervention.
rBMT, Then rSLT, Then no Therapy
n=6 Participants
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total. Then participants could be enrolled in the rSLT group, and after 6-month completion again into the 'no-therapy' group.
No Therapy, Then rSLT or rBMT, Then rBMT or rSLT
n=6 Participants
"the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time. After 6-month completion, participants could enrol in the rSLT or the rBMT intervention program, and then upon 6-month completion again in the opposite intervention program, being rBMT or rSLT, respectively.
Healthy Controls; no Therapy
n=17 Participants
Healthy Controls received no therapy.
Total
n=37 Participants
Total of all reporting groups
Age, Continuous
69.4 years
STANDARD_DEVIATION 7.1 • n=8 Participants
69.9 years
STANDARD_DEVIATION 6.7 • n=6 Participants
65.1 years
STANDARD_DEVIATION 6.7 • n=6 Participants
67.9 years
STANDARD_DEVIATION 5.2 • n=17 Participants
68.9 years
STANDARD_DEVIATION 6.3 • n=37 Participants
Sex: Female, Male
Female
3 Participants
n=8 Participants
3 Participants
n=6 Participants
2 Participants
n=6 Participants
10 Participants
n=17 Participants
18 Participants
n=37 Participants
Sex: Female, Male
Male
5 Participants
n=8 Participants
3 Participants
n=6 Participants
4 Participants
n=6 Participants
7 Participants
n=17 Participants
19 Participants
n=37 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Switzerland
8 participants
n=8 Participants
6 participants
n=6 Participants
6 participants
n=6 Participants
17 participants
n=17 Participants
37 participants
n=37 Participants
Speech Velocity
5.3 spoken syllables per second
STANDARD_DEVIATION .6 • n=8 Participants
5.3 spoken syllables per second
STANDARD_DEVIATION .6 • n=6 Participants
4.9 spoken syllables per second
STANDARD_DEVIATION .4 • n=6 Participants
2.3 spoken syllables per second
STANDARD_DEVIATION 1.6 • n=17 Participants
4.4 spoken syllables per second
STANDARD_DEVIATION 1.4 • n=37 Participants
Speech Cadence
8.4 Spoken syllables per inspiration
STANDARD_DEVIATION 3.5 • n=8 Participants
9 Spoken syllables per inspiration
STANDARD_DEVIATION 3.9 • n=6 Participants
8.2 Spoken syllables per inspiration
STANDARD_DEVIATION .6 • n=6 Participants
21.6 Spoken syllables per inspiration
STANDARD_DEVIATION .6 • n=17 Participants
12.2 Spoken syllables per inspiration
STANDARD_DEVIATION 7.4 • n=37 Participants
Gait velocity
1.3 meters per second
STANDARD_DEVIATION .4 • n=8 Participants
1.2 meters per second
STANDARD_DEVIATION .4 • n=6 Participants
1.2 meters per second
STANDARD_DEVIATION .3 • n=6 Participants
.8 meters per second
STANDARD_DEVIATION .08 • n=17 Participants
1.2 meters per second
STANDARD_DEVIATION .4 • n=37 Participants
Gait Cadence
2.7 steps per second
STANDARD_DEVIATION .8 • n=8 Participants
2.7 steps per second
STANDARD_DEVIATION .8 • n=6 Participants
2.7 steps per second
STANDARD_DEVIATION .7 • n=6 Participants
1.7 steps per second
STANDARD_DEVIATION .2 • n=17 Participants
2.5 steps per second
STANDARD_DEVIATION .8 • n=37 Participants

PRIMARY outcome

Timeframe: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).

Gait Velocity: meters per second

Outcome measures

Outcome measures
Measure
Specific SL-therapy for PD-DBS and Non-DBS
n=16 Participants
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.
rBMT for PD-DBS and Non-DBS
n=10 Participants
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
PD-DBS/ Non-DBS; no Therapy
n=18 Participants
"the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time.
Healthy Controls; no Therapy
n=17 Participants
Healthy Controls received no therapy.
Velocity in Gait
Gait Velocity-4W (4Weeks)
1.2 meter per second
Standard Deviation .2
1.2 meter per second
Standard Deviation .3
1.2 meter per second
Standard Deviation .3
.8 meter per second
Standard Deviation .08
Velocity in Gait
Gait Velocity-6M (6 Months)
1.3 meter per second
Standard Deviation .8
1.2 meter per second
Standard Deviation .4
1.2 meter per second
Standard Deviation .3
.8 meter per second
Standard Deviation .08

PRIMARY outcome

Timeframe: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).

4-Weeks and 6-Months Follow-up. To measure rhythmicity in gait, participants walked 6 metres at their individual pace. They were timed and amount of steps were counted.

Outcome measures

Outcome measures
Measure
Specific SL-therapy for PD-DBS and Non-DBS
n=16 Participants
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.
rBMT for PD-DBS and Non-DBS
n=10 Participants
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
PD-DBS/ Non-DBS; no Therapy
n=18 Participants
"the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time.
Healthy Controls; no Therapy
n=17 Participants
Healthy Controls received no therapy.
Cadence in Gait
Gait Cadence-6M
2.8 steps per second
Standard Deviation .8
2.7 steps per second
Standard Deviation .8
2.7 steps per second
Standard Deviation .7
1.7 steps per second
Standard Deviation .2
Cadence in Gait
Gait Cadence-4W
2.5 steps per second
Standard Deviation .3
2.5 steps per second
Standard Deviation .6
2.7 steps per second
Standard Deviation .7
1.7 steps per second
Standard Deviation .2

PRIMARY outcome

Timeframe: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).

Speech Velocity at 4 weeks and at 6 months To measure rhythmicity in speech, participants read a text aloud ('the north wind and the sun') and were recorded using an Olympus. According to these speech samples, the count of elicited syllables per second was calculated.

Outcome measures

Outcome measures
Measure
Specific SL-therapy for PD-DBS and Non-DBS
n=16 Participants
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.
rBMT for PD-DBS and Non-DBS
n=10 Participants
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
PD-DBS/ Non-DBS; no Therapy
n=18 Participants
"the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time.
Healthy Controls; no Therapy
n=17 Participants
Healthy Controls received no therapy.
Speech Velocity
Speech velocity 6M
3.8 spoken syllables per second
Standard Deviation .8
4.8 spoken syllables per second
Standard Deviation .9
4.9 spoken syllables per second
Standard Deviation .6
2.3 spoken syllables per second
Standard Deviation .6
Speech Velocity
Speech velocity 4W
3.6 spoken syllables per second
Standard Deviation .7
4.2 spoken syllables per second
Standard Deviation .9
4.9 spoken syllables per second
Standard Deviation .7
2.3 spoken syllables per second
Standard Deviation .6

PRIMARY outcome

Timeframe: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).

Speech Cadence 4 Weeks and at 6 Months To measure rhythmicity in speech, participants' speech was recorded while reading a text aloud ('the north wind and the sun'). Elicited syllables per inspiration were analysed.

Outcome measures

Outcome measures
Measure
Specific SL-therapy for PD-DBS and Non-DBS
n=16 Participants
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.
rBMT for PD-DBS and Non-DBS
n=10 Participants
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
PD-DBS/ Non-DBS; no Therapy
n=18 Participants
"the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time.
Healthy Controls; no Therapy
n=17 Participants
Healthy Controls received no therapy.
Speech Cadence
Speech Cadence 6M
13.3 spoken syllables per inspiration
Standard Deviation 4.6
13.6 spoken syllables per inspiration
Standard Deviation 4.7
10.5 spoken syllables per inspiration
Standard Deviation 3.5
21.6 spoken syllables per inspiration
Standard Deviation 6
Speech Cadence
Speech Cadence 4W
15.6 spoken syllables per inspiration
Standard Deviation 3.6
13.1 spoken syllables per inspiration
Standard Deviation 4.7
10.9 spoken syllables per inspiration
Standard Deviation 3.9
21.6 spoken syllables per inspiration
Standard Deviation 6

SECONDARY outcome

Timeframe: At Baseline and 6 Months

The complete questionnaire 'Unified Parkinson's Disease Rating Scale' (UPDRS) was filled out at BL and 6M. Scores may range from 0-4 per question. Final scores may add up to 199 points maximum. The higher the score, the worse disease severity/ degree of disability is.

Outcome measures

Outcome measures
Measure
Specific SL-therapy for PD-DBS and Non-DBS
n=16 Participants
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.
rBMT for PD-DBS and Non-DBS
n=10 Participants
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
PD-DBS/ Non-DBS; no Therapy
n=18 Participants
"the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time.
Healthy Controls; no Therapy
n=17 Participants
Healthy Controls received no therapy.
Health Status (UPDRS)
UPDRS-BL
38.6 score on a scale
Standard Deviation 19.1
37.3 score on a scale
Standard Deviation 20.6
42.8 score on a scale
Standard Deviation 20.2
0 score on a scale
Standard Deviation 0
Health Status (UPDRS)
UPDRS-6M
35.6 score on a scale
Standard Deviation 16.7
41.7 score on a scale
Standard Deviation 19.1
37 score on a scale
Standard Deviation 20.1
0 score on a scale
Standard Deviation 0

SECONDARY outcome

Timeframe: At 4 Weeks and 6 Months

Self-rating questionnaires investigating depression using the Beck's Depression Inventory (BDI). This is a 21 question, multiple choice, self-report questionnaire. Minimum score is 0 and maximum scores is 63. The higher the score the more severe is the depression. Details: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.

Outcome measures

Outcome measures
Measure
Specific SL-therapy for PD-DBS and Non-DBS
n=16 Participants
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.
rBMT for PD-DBS and Non-DBS
n=10 Participants
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
PD-DBS/ Non-DBS; no Therapy
n=18 Participants
"the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time.
Healthy Controls; no Therapy
n=17 Participants
Healthy Controls received no therapy.
Neuropsychiatric Self-rating Questionnaires
BDI-4W
8 score
Standard Deviation 1.8
7.6 score
Standard Deviation 2.1
7.1 score
Standard Deviation 1.9
5.5 score
Standard Deviation 2.2
Neuropsychiatric Self-rating Questionnaires
BDI-6M
7.4 score
Standard Deviation 1.7
8.8 score
Standard Deviation 1.6
8.3 score
Standard Deviation 1.8
5.4 score
Standard Deviation 2.2

SECONDARY outcome

Timeframe: At 4 Weeks and at 6 Months

Inhibition Control (Stroop), Visio-Construction (Mosaic), Flexibility (Trail Making Test), Episodic Memory (Basel Verbal Learning Test -long delayed free recall), Working Memory (backwards digit span task by Wechsler). Scores were standardized (z-scores) to a mean of 0 and standard deviation of 1. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population

Outcome measures

Outcome measures
Measure
Specific SL-therapy for PD-DBS and Non-DBS
n=16 Participants
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.
rBMT for PD-DBS and Non-DBS
n=10 Participants
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
PD-DBS/ Non-DBS; no Therapy
n=18 Participants
"the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time.
Healthy Controls; no Therapy
n=17 Participants
Healthy Controls received no therapy.
Neuropsychological Standardised Test Battery
Episodic Memory-4W
-.9 z-scores
Standard Deviation 1.7
-.3 z-scores
Standard Deviation 1.2
-.7 z-scores
Standard Deviation .3
-.4 z-scores
Standard Deviation 1.7
Neuropsychological Standardised Test Battery
Episodic Memory-6M
-.7 z-scores
Standard Deviation 1.5
-.6 z-scores
Standard Deviation .8
-.3 z-scores
Standard Deviation 1.1
-.2 z-scores
Standard Deviation 1.1
Neuropsychological Standardised Test Battery
Working Memory-4W
.6 z-scores
Standard Deviation .8
.2 z-scores
Standard Deviation .9
-.2 z-scores
Standard Deviation .8
.1 z-scores
Standard Deviation 1.7
Neuropsychological Standardised Test Battery
Working Memory-6M
-.3 z-scores
Standard Deviation 1.1
.13 z-scores
Standard Deviation .9
-.2 z-scores
Standard Deviation .8
-.5 z-scores
Standard Deviation 1.4
Neuropsychological Standardised Test Battery
Visuo-Construction-4W
.4 z-scores
Standard Deviation 1.03
.14 z-scores
Standard Deviation 1.1
.4 z-scores
Standard Deviation .9
.4 z-scores
Standard Deviation .8
Neuropsychological Standardised Test Battery
Visa-Construction-6M
.03 z-scores
Standard Deviation 1
.07 z-scores
Standard Deviation .9
.2 z-scores
Standard Deviation .6
.8 z-scores
Standard Deviation 1.05
Neuropsychological Standardised Test Battery
Inhibition (Stroop)-4W
.6 z-scores
Standard Deviation .8
.8 z-scores
Standard Deviation 1.4
.7 z-scores
Standard Deviation .9
.2 z-scores
Standard Deviation 1.3
Neuropsychological Standardised Test Battery
Inhibition (Stroop)-6M
-.04 z-scores
Standard Deviation .9
.3 z-scores
Standard Deviation .6
.7 z-scores
Standard Deviation .7
.4 z-scores
Standard Deviation .7
Neuropsychological Standardised Test Battery
Flexibility (TMT)-4W
-.4 z-scores
Standard Deviation .8
-.6 z-scores
Standard Deviation 1.3
-.8 z-scores
Standard Deviation .3
.2 z-scores
Standard Deviation 1.05
Neuropsychological Standardised Test Battery
Flexibility (TMT)-6M
-.6 z-scores
Standard Deviation 1.02
-1.2 z-scores
Standard Deviation 1.1
-.3 z-scores
Standard Deviation .8
.8 z-scores
Standard Deviation 1.3

Adverse Events

Specific SL-therapy for PD-DBS and Non-DBS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

rBMT for PD-DBS and Non-DBS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

PD-DBS/ Non-DBS; no Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy Controls; no Therapy

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

Prof. Peter Fuhr

University Hospital Basel

Phone: 0041 61 265

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place