A Double Blind Sham-controled Study to Evaluate the Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease

NCT ID: NCT01367782

Last Updated: 2014-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD), to establish its safety in this population and to test effects of maintenance treatments.

Detailed Description

PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while "off" will be recruited. Participants on antidepressants should be at least 2 months on stable therapy.

Patient will be excluded if:

1. Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.

2. Patients on neuroleptics.

3. Patients with unstable medical disorder.

4. History or current unstable hypertension.

5. History of head injury or neurosurgical interventions.

6. History of any metal in the head (outside the mouth).

7. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.

8. History of migraine or frequent or severe headaches.

9. Current hearing loss.

10. The presence of cochlear implants

11. Current drug abuse or alcoholism.

12. Pregnancy or not using a reliable method of birth control.

13. Participation in current clinical study or clinical study within 30 days prior to this study.

Patients will be to randomized to an active rTMS arm or to a sham stimulation arm. Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks.

Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes). The control arm group will receive sham stimulations in identical treatment and maintenance schedules. Patients from the sham group who will complete the study will be given the opportunity to receive 12 sessions of real r-TMS treatment over 4 weeks as the treatment group.

The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30, 60 and 90. Evaluation will be while subjects are both at "on" and "off".

Motor:

1. Unified Parkinson's Disease Rating Scale (UPDRS )

2. Clinical Global Impression of Severity (CGIS)

3. Pegboard test.

4. Tapping test

5. Up & Go test

6. Abnormal Involuntary Movement Scale (AIMS) Mood and affect

1. Beck Depression Inventory (BDI) Cognition

1. Mini mental State examination (MMSE)

2. Digit forward and backward tests.

3. Word fluency.

4. Frontal Assessment Battery (FAB)

Side effects will be closely monitored by the researchers and will be promptly reported to the IRB.

Conditions

Asymmetric Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active repetitive Transcranial Stimulation

Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks.

Group Type: ACTIVE_COMPARATOR

repetitive transcranial stimulation (r-TMS)

Intervention Type: DEVICE

Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes).

Sham Stimulation

The control arm group will receive sham stimulations in identical treatment and maintenance schedules.

Group Type: SHAM_COMPARATOR

repetitive transcranial stimulation (r-TMS)

Intervention Type: DEVICE

Sham treatment with the H-coil will include sham stimulation over the motor cortex and over the prefrontal cortex.

Interventions

repetitive transcranial stimulation (r-TMS)

Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes).

Intervention Type: DEVICE

repetitive transcranial stimulation (r-TMS)

Sham treatment with the H-coil will include sham stimulation over the motor cortex and over the prefrontal cortex.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while "off".
• Participants on antidepressants should be at least 2 months on stable therapy.

Exclusion Criteria

1. Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.

2. Patients on neuroleptics.

3. Patients with unstable medical disorder.

4. History or current unstable hypertension.

5. History of head injury or neurosurgical interventions.

6. History of any metal in the head (outside the mouth).

7. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.

8. History of migraine or frequent or severe headaches.

9. Current hearing loss.

10. The presence of cochlear implants

11. Current drug abuse or alcoholism.

12. Pregnancy or not using a reliable method of birth control.

13. Participation in current clinical study or clinical study within 30 days prior to this study.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainsway

INDUSTRY

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Oren Cohen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oren Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Oren Cohen, MD

Role: CONTACT

Oren.Cohen@sheba.health.gov.il

+972-3-5305296

Facility Contacts

Oren Cohen, MD

Role: primary

Oren.Cohen@sheba.health.gov.il

Other Identifiers

SHEBA-11-8470-OC-CTIL

Identifier Type: -

Identifier Source: org_study_id