Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient

NCT ID: NCT01143649

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke.

The investigators hypothesis is that active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) will induce a greater motor function improvement as compared with sham tDCS combined with CIMT.

Detailed Description

In this 3 experiments study we will evaluate the effect of tDCS and constraint induced movement therapy (CIMT) in stroke patients (exp 1) as well as in healthy subjects (control population - exp 2). Finally we will investigate the effect of tACS - transcranial alternating current stimulation - as an alternative to tDCS, on motor function in healthy subjects (exp 3). The two experiments on tDCS are parallels (exp 1 & 2), while the experiment on tACS uses a crossover design (exp 3).

For stroke patients (Exp1), our primary outcome measure is a clinical scale (Jebsen-Taylor Hand Function Test), while for healthy subjects (Exp 2) we investigate the effect of tDCS and CIMIT on cortico-spinal excitability using TMS - transcranial magnetic stimulation. Finally, for the third experiment using tACS, our primary outcome is cortical oscillation, as measured by EEG - electroencephalogram.

Conditions

Stroke; Healthy

Study Design

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

Study Groups

active tDCS + CIMT - stroke patients

Participants will receive 5 sessions of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT - 10 consecutive sessions Monday- Friday).

Group Type: EXPERIMENTAL

transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Subjects will be stimulated at 1 mA for 40 minutes.

constraint induced movement therapy (CIMT)

Intervention Type: PROCEDURE

active tDCS + CIMT - Healthy

Participants will receive one session of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT)

Group Type: EXPERIMENTAL

transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Subjects will be stimulated at 1 mA for 40 minutes.

constraint induced movement therapy (CIMT)

Intervention Type: PROCEDURE

tACS - Healthy Subjects

The investigators will have 40 healthy subjects who will undergo one session of treatment with active tACS (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized).

Group Type: EXPERIMENTAL

transcranial alternating current stimulation (tACS)

Intervention Type: DEVICE

Subjects will be stimulated at 15Hz for 20 minutes.

sham tDCS + CIMT - stroke patients

Participants will receive 5 sessions of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT - 10 consecutive sessions Monday- Friday). For the sham session, tDCS is turned off after 30seconds.

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Subjects will be stimulated at 1 mA for 40 minutes.

constraint induced movement therapy (CIMT)

Intervention Type: PROCEDURE

sham tDCS + CIMT - Healthy

Participants will receive one session of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT). The sham stimulation consists of 30 seconds of stimulation at the beginning of the 40 min of treatment.

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Subjects will be stimulated at 1 mA for 40 minutes.

constraint induced movement therapy (CIMT)

Intervention Type: PROCEDURE

sham tACS - Healthy Subjects

The investigators will have 40 healthy subjects who will undergo one day of treatment with sham tACS. All participants received active and sham stimulation in a randomized order.

Group Type: SHAM_COMPARATOR

transcranial alternating current stimulation (tACS)

Intervention Type: DEVICE

Subjects will be stimulated at 15Hz for 20 minutes.

Interventions

transcranial direct current stimulation (tDCS)

Subjects will be stimulated at 1 mA for 40 minutes.

Intervention Type: DEVICE

constraint induced movement therapy (CIMT)

Intervention Type: PROCEDURE

transcranial alternating current stimulation (tACS)

Subjects will be stimulated at 15Hz for 20 minutes.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

All subjects must be between the ages of 18-90 and must not be pregnant.

Additional Entry criteria for Stroke subject enrollment:

1. First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report;

2. Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale

3. Stroke onset >6 months prior to study enrollment.

Exclusion Criteria

1. Significant pre-stroke disability;

2. Major depression, as defined by Hamilton Depression (HAM-D) scale grater then or equal 17 if needed (history of depression before the stroke);

3. Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing;

4. Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects);

5. Contraindications to single pulse Transcranial Magnetic Stimulation (TMS) (TMS will be used to measure cortical excitability) such as metal head implants

• history of seizures
• unexplained loss of consciousness
• metal in the head
• frequent or severe headaches or neck pain
• implanted brain medical devices.

6. Contraindications to tDCS

• metal in the head
• implanted brain medical devices

7. Advanced liver, kidney, cardiac, or pulmonary disease;

8. A terminal medical diagnosis consistent with survival < 1 year;

9. Coexistent major neurological or psychiatric disease as to decrease number of confounders;

10. A history of significant alcohol or drug abuse in the prior 6 months;

11. Use of carbamazepine and amitriptyline;

12. Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and

13. Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke;

14. History of epilepsy before stroke (or episodes of seizures within the last six months).

15. Subjects with global aphasia and deficits of comprehension

16. Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, PhD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

References

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

Reference Type: DERIVED

PMID: 33175411 (View on PubMed)

Other Identifiers

2009p001808

Identifier Type: -

Identifier Source: org_study_id